A REVIEW OF ANALYTICAL TECHNIQUES FOR DETERMINATION OF ANTI-HIV DRUGS

  • RAJEEV KUMAR MISHRA Sri Satya Sai University of Technology and Medical Science sehore M. P. India
  • NEELESH CHAUBEY Sri Satya Sai University of Technology and Medical Science sehore M. P. India
  • JAY RAM PATEL Rungta Institute of Pharmaceutical Science and Research, Bhilai Durg C. G. India
  • SATISH MISHRA Gulabkali Memorial College of Pharmacy Chakghat Rewa M. P India
  • ROHIT SINGH Aditya College of Pharmacy Satna M. P. India

Abstract

Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations. Rapid increase in pharmaceutical industries and production of drug in various parts of the world has brought a rise in demand for new analytical techniques in the pharmaceutical industries. As a consequence, analytical method development has become the basic activity of analysis. From the times of yore, people were trying to find safe and sound ways to treat viral infections. In the current scenario, due to the emerging of new viruses, the development of drugs for their treatment is also gaining equal importance. Before launching to the market, these drugs should undergo a validation process. High-performance liquid chromatography (HPLC) coupled with ultraviolet (UV), Photodiode array detectors (PDA), Mass spectrophotometer (MS) detectors etc. is one of the fastest, safe and precise technologies used for determination and separation of pharmaceutical drugs, impurities and biological samples. HPLC is versatile and it takes less time for quantification of drugs as compared to old liquid chromatography techniques. Tenofovir disoproxil fumarate (TDF), Emtricitabine (FTC) and Efavirenz (EFV) is antiretroviral medicine used treat AIDS as well as chronic Hepatitis-B. It is used alone or with other HIV medications to help control HIV infection. The present review article assesses the published analytical methods and a variety of approach for investigation of TDF, FTC and EFV in bulk drug as well as pharmaceutical formulations including combinations. The present studies revealed that HPLC technique along with the spectroscopic have been most widely explored for the analysis. The investigatory review may provide the comprehensive details to the researchers who are working in the area of analytical research of TDF, FTC and EFV.

Keywords: Pharmaceutical analysis, High-performance liquid chromatography, Tenofovir disoproxil fumarate, Emtricitabine, Efavirenz

References

1. Parr MK, Schmidt AH. Life cycle management of analytical methods. J Pharm Biomed Anal 2018;147:506-17.
2. Gaudin K, Ferey L. Quality by design: a tool for separation method development in pharmaceutical laboratories. LC-GC 2016;29:16-25.
3. Maggio RM, Vignaduzzo SE, Kaufman TS. Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations. TrAC, Trends Anal Chem 2013;49:57-70.
4. Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-a review. J Pharm Anal 2014;4:159-65.
5. Singh S, Junwal M, Modhe G, Tiwari H, Kurmi M, Parashar N, et al. Forced degradation studies to assess the stability of drugs and products. TrAC, Trends Anal Chem 2013;49:71-88.
6. ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products Q1A (R2), current Step 4 version; International Conference on Harmonisation: Geneva; 2003.
7. Global report: UNAIDS report on the global AIDS epidemic; 2012.
8. Zagury D, Bernard J, Leibowitch J, Safai B, Groopman JE, Feldman M, et al. HTLV-III in cells cultured from semen of two patients with AIDS. Science 1984;226:449-51.
9. Vogt MW, Witt DJ, Craven DE, Byington R, Crawford DF, Schooley RT, et al. Isolation of HTLV-III/lAV from cervical secretions of women at risk for AIDS. Lancet 1986;1:525-7.
10. Friedland GH, Klein RS. Transmission of the human immunodeficiency virus. N Engl J Med 1987;317:1125-35.
11. Chermann JC. Sexual and mother-to-child transmission of the human immunodeficiency virus type 1: a review. Am J Reprod Immunol 1998;40:183-6.
12. Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, et al. Changing patterns of mortality across Europe in patients infected with HIV-1. Euro SIDA Study Group. Lancet 1998;45:1093-9.
13. Palella FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV outpatient study investigators. N Engl J Med 1998;338:853-60.
14. Vittinghoff E, Scheer S, O’Malley P, Colfax G, Holmberg SD, Buchbinder SP. Combination antiretroviral therapy and recent declines in AIDS incidence and mortality. J Infect Dis 1999;179:717-20.
15. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010;363:2587-99.
16. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505.
17. Centers for Disease Control and Prevention (CDC). Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011;60:65-8.
18. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367:399-410.
19. Food, Drug Administration, FDA-approved ARV drugs; 2020.
20. Volberding PA, Deeks SG. Antiretroviral therapy and management of HIV infections. Lancet 2010;376:49-62.
21. Capetti A, Astuti N, Cossu MV, Rizzardini G, Carenzi L. The role of therapeutic drug monitoring and pharmacogenetic testing in the management of HIV infection: a review. J Aids Clin Res 2015;6:11-9.
22. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services; 2015.
23. Burcin B, Bengi U, Ozkan SA. A review of electroanalytical techniques for determination of anti-HIV drugs. Int J Electrochem 2011. https://doi.org/10.4061/2011/343947
24. Echenique IA, Rich JD. EFV/FTC/TDF-associated hepatotoxicity: a case report and review. AIDS Patient Care STDs 2013;27:493–7.
25. Aspen Pharmacare, “TribussTM,”; 2011.
26. Zamisa T. HIV patients revel in the one pill a day age; 2014.
27. European Medicines Agency, Summary of product characteristics: Viread 245 mg film-coated tablets; 2007.
28. Deeks ED, Perry CM, Efavirenz/emtricitabine/tenofovir disoproxil fumarate single tablet regimen (Atripla®): a review of its use in the management of HIV infection. Drugs 2010;70:2315–38.
29. Takahashi M, Kudaka Y, Okumura N, Hirano A, Banno K, Kaneda T. Determination of plasma tenofovir concentrations using a conventional LC-MS method. Biol Pharm Bull 2007;30:1784-6.
30. Llibre JM, Clotet B. Once-daily single-tablet regimens: a long and winding road to excellence in antiretroviral treatment. AIDS Rev 2012;14:168–8.
31. Pedersen OS, Pedersen EB. Non-nucleoside reverse transcriptase inhibitors: the NNRTI boom. Antivir Chem Chemother 1999;10:285-314.
32. Nadal T, Ortuno J, Pascual JA. Rapid and sensitive determination of zidovudine and zidovudine glucuronide in human plasma by ion-pair high-performance liquid chromatography. J Chromatogr A 1996;721:127-37.
33. Food and Drug Administration. Full prescribing information, ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets. Gilead Sciences; 2013.
34. World Health Organisation, Emtricitabine monograph, 4th ed. The International Pharmacopoiea; 2009.
35. AIDS Info, Emtricitabine; 2014.
36. National Center for Biotechnology Information, Emtricitabine; 2005.
37. Dando TM, Wagstaff AJ. Emtricitabine/tenofovir disoproxil fumarate. Drugs 2004;64:2075-82.
38. Avihingsanon A, Lewin SR, Kerr S, Chang JJ, Piyawat K, Napissanant N, et al. Efficacy of tenofovir disoproxil fumarate/emtricitabine compared with emtricitabine alone in antiretroviral-naive HIV-HBV coinfection in Thailand. Antivir Ther 2010;15:917-22.
39. Moody W. Truvada works to block HIV transmission. Echo Mag 2012;24:66-7.
40. Wang LH, Wiznia AA, Rathore MH, Chittick GE, Bakshi SS, Emmanuel PJ, et al. Pharmacokinetics and safety of single oral doses of emtricitabine in human immunodeficiency virus-infected children. Antimicrob Agents Chemother 2004;48:183-91.
41. Hamarapurkar PD, Parate AN, HPLC method for the determination of emtricitabine and related degradation substances. J Chromatogr Sci 2013;51:419–24.
42. Menendez Arias L. Mechanisms of resistance to nucleoside analogue inhibitors of HIV-1 reverse transcriptase. Virus Res 2008;134:124–46.
43. Chen A, Dowdy DW. Clinical effectiveness and cost-effectiveness of HIV pre exposure prophylaxis in men who have sex with men: risk calculators for real-world decision-making. PLoS One 2014;9:108742.
44. Medicines Control Council, Press release: Medicines Control Council approves fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine for pre-exposure prophylaxis of HIV. Department of Health; 2015.
45. Varghese V, Wang E, Babrzadeh F, Bachmann MH, Shahriar R, Liu T, et al. Nucleic acid template and the risk of a PCR-Induced HIV-1 drug resistance mutation. PLoS One 2010;5:10992.
46. Boucher S, Recordon Pinson P, Ragnaud JM, Dupon M, Fleury H, Masquelier B. HIV-1 reverse transcriptase (RT) genotypic patterns and treatment characteristics associated with the K65R RT mutation. HIV Med 2006;7:294–8.
47. Gallant JE, Parish MA, Keruly JC, Moore RD. Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse transcriptase inhibitor treatment. Clin Infect Dis Publ Infect Dis Soc Am 2005;40:1194–8.
48. Calza L, Trapani F, Salvadori C, Magistrelli E, Manfredi R, Colangeli V, et al. Incidence of renal toxicity in HIV-infected, antiretroviral-naïve patients starting tenofovir/emtricitabine associated with efavirenz, atazanavir/ritonavir, or lopinavir/ritonavir. Scand J Infect Dis 2013;45:147–54.
49. Deeks SG, Barditch Crovo P, Lietman PS, Hwang F, Cundy KC, Rooney JF, et al. Safety, pharmacokinetics, and antiretroviral activity of 114 intravenous 9-[2-(R)-(Phosphonomethoxy)propyl]adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adults. Antimicrob Agents Chemother 1998;42:2380–4.
50. Chapman T, McGavin J, Noble S. Tenofovir disoproxil fumarate. Drugs 2003;63:1597-608.
51. World Health Organisation, Tenofovir monograph; 2010.
52. AIDS Info, Tenofovir disoproxil fumarate; 2013.
53. Food and Drug Administration, “Full prescribing information, COMPLERA® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate).” Gilead Sciences; 2014.
54. Kearney BP, Flaherty JF, Shah J. Tenofovir disoproxil fumarate: clinical pharmacology and pharmacokinetics. Clin Pharmacokinet 2004;43:595-612.
55. Gervasoni C, Meraviglia P, Landonio S, Baldelli S, Fucile S, Castagnoli L, et al. Low body weight in females is a risk factor for increased tenofovir exposure and drug-related adverse events. PLoS One 2013;8:8-13.
56. Delahunty T, Bushman L, Fletcher CV. Sensitive assay for determining plasma tenofovir concentrations by LC/MS/MS. J Chromatogr B: Anal Technol Biomed Life Sci 2006;830:6-12.
57. Maggiolo F. Efavirenz: a decade of clinical experience in the treatment of HIV. J Antimicrob Chemother 2009;64:910-28.
58. Food and Drug Administration, “Full prescribing information, ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets.” Gilead Sciences; 2013.
59. World Health Organisation, Efavirenz monograph; 2005.
60. AIDS Info, Efavirenz; 2014.
61. Sathigari S, Chadha G, Lee YHP, Wright N, Parsons DL, Rangari VK, et al. Physicochemical characterization of efavirenz-cyclodextrin inclusion complexes. AAPS PharmSciTech 2009;10:81–7.
62. McIlleron HM. Effects of rifampin-based antituberculosis therapy on plasma efavirenz concentrations in children vary by CYP2B6 genotype. AIDS 2013;27:1933-40.
63. Friedland G, Khoo S, Jack C, Lalloo U. Administration of efavirenz [600 mg/day] with rifampicin results in highly variable levels but excellent clinical outcomes in patients treated for tuberculosis and HIV. J Antimicrob Chemother 2006;58:1299-302.
64. Cristofoletti R, Nair A, Abrahamsson B, Groot DW, Kopp S, Langguth P, et al. Biowaiver monographs for immediate release solid oral dosage forms: efavirenz. J Pharm Sci 2013;102:318–29.
65. Rabel SR, Patel M, Sun S, Maurin MB. Electronic and resonance effects on the ionization of structural analogues of efavirenz. AAPS Pharm Sci 2001;3:28.
66. AIDS Info, Emtricitabine/tenofovir disoproxil fumarate; 2015.
67. Takagi T, Ramachandran C, Bermejo M, Yamashita S, Yu LX, Amidon GL. A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan. Mol Pharm 2006;3:631–43.
68. World Health Organisation. General notes on biopharmaceutics classification system (BCS)-based biowaiver applications; 2011.
69. Drug Bank, Efavirenz; 2013.
70. Drug Bank, Emtricitabine; 2013.
71. Drug Bank, Tenofovir; 2013.
72. Rele RV, Patil SP. Development of analytical method by RP-HPLC method for validation of emtricitabine in api and pharmaceutical dosage form. Asian J Res Chem 2019;12:143-7.
73. Singh G, Pai RS. Optimization (Central Composite Design) and validation of HPLC method for investigation of emtricitabine loaded poly (lactic-co-glycolic acid) nanoparticles: in vitro drug release and in vivo pharmacokinetic studies. Sci World J 2014. DOI:10.1155/2014/583090
74. Singh G, Pai RS. High-performance liquid chromatographic method for analysis of emtricitabine in rat plasma: method development, validation and application to a pharmacokinetic study. ISRN Chromatography 2013;3:1-16.
75. Kumar P, Dwivedi SC, Kushnoor A. A validated stability indicating RPHPLC method for the determination of emtricitabine in bulk and capsules. Farmacia 2012;60:402-10.
76. Patel BN, Suhagia BN, Patel CN. Development and validation of HPLC method for the estimation of emtricitabine in capsule dosage form. Asian J Chem 2010;3:869-71.
77. Jampala RR, Kumar VK, Nemala AR. Development and application of liquid chromatographic method for simultaneous determination of elvitegravir, tenofovir disoproxil fumarate, emtricitabine, and cobicistat in fixed dosage form. Pharm Methods 2014;5:7-13.
78. Venkatesh M, Sumanth ALMN, Rao PV. Analytical method development and validation of simultenious estimation of tenofovir and emtricitabine in bulk and pharmaceutical dosageforms by using RP-HPLC. Asian J Pharm Anal Med Chem 2013;1:60-9.
79. Kiran KK, Rao AS, Sankar DG. New validated, optimized and forced degradation study for the simultaneous estimation of rilpivirine, emtricitabine, and tenofovir alafenamide in bulk and pharmaceutical dosage preparations by RP-HPLC. Asian J Pharm Anal Med Chem 2017;5:170-87.
80. Sattar MDA, Achanta S. Analytical method development and validation for the determination of emtricitabine and tenofovir disoproxil fumarate using reverse phase HPLC method in bulk and tablet dosage form. J Pharm Sci Res 2018;10:1207-12.
81. Akram NMD, Umamahesh M. A new validated RP-HPLC method for the determination of emtricitabine and tenofovir af in its bulk and pharmaceutical dosage forms. J Chem Pharm Sci 2017;10:54-9.
82. Ashok G, Mondal S. Development and validation of stability indicating method for the simultaneous quantification of emtricitabine, tenofovir disoproxil fumarate and rilpivirine hydrochloride in pharmaceutical dosage forms by RP-HPLC. Saudi J Med Pharm Sci 2018;4:175-83.
83. Gummaluri RK, Parthasarathi TVN, Anjanamadhulika G. Simultaneous method for determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat in tablets by HPLC. Indian J Pharm Sci 2016;78:532-7.
84. Soni A, Thakral S. Simultaneous estimation of tenofovir and emtricitabine in human plasma using HPLC after protein precipitation extraction. J Anal Bioanal Tech 2013;4:170.
85. Pranitha D, Vanitha C, Francis P, Raja MA, Vardan PV, Surendar M, et al. Simultaneous estimation of emtricitabine, tenofovir disoproxil fumarate, and rilpivirine in bulk form by RP-HPLC method. J Pharm Res 2012;5:4600-2.
86. Gopal NM, Sridhar C. Reverse phase UPLC method for simultaneous estimation of emtricitabine and tenofovir in tablet dosage form. J Sci Res Pharm 2017;6:11-7.
87. Basha A, Sireesha D, Anil D, Talla R, Haque MA, Harshini S, et al. Method development and validation for simultaneous estimation of tenofovir disoproxil fumarate and emtricitabine in pharmaceutical dosage form by RP-HPLC method. Int J Innovative Pharm Sci Res 2015;3:1537-45.
88. Muthyala S, Kumari RVV. Stability indicating RP-HPLC method for simultaneous estimation of emtricitabine, bictegravir and tenofovir alafenamide in bulk and formulation. Int J Pharm Anal Res 2019;8:281-92.
89. Reddy BRY, Reddy MT, Reddy BSC. Simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form by reverse phase high-performance liquid chromatography. SOJ Chromatograph Sci 2015;1:6.
90. Runja C, Kumar PR, Avanapu SR. A validated stability indicating RP-HPLC method for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat in pharmaceutical dosage form. J Chromatographic Sci 2016;54:759–64.
91. Karunakaran AK, Kamarajan K, Thangarasu V. A validated RP-HPLC method for simulataneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and in tablet dosage form. Pharm Sinica 2010;1:52-60.
92. Purnima BV, Reddy TVB, Rao YS, Ramu G, Ramachandran D. Stability indicating RP-UPLC method for assay of emtricitabine and tenofovir disoproxil fumarate in bulk and dosage forms. Am J Anal Chem 2015;6:807-21.
93. Sharma R, Gupta P. A validated RP-HPLC method for simulataneous estimation of emtricitabine and tenofovir disoproxil fumarate in a tablet dosage form. Eurasian J Anal Chem 2009;4:276-84.
94. Joshi NC, Kumar P, Jat RK. Development and validation of RP-HPLC method for the estimation of antiretroviral drugs and their pharmaceutical formulations. Pharmacophore 2016;7:152-65.
95. Purnima VB, Reddy TVB, Suneetha Y, Ramachandran D. Simultaneous determination of antiretroviral drugs emtricitabine and tenofovir desoproxil fumerate by a stability indicating RP-HPLC method. Int J Pharm Pharm Sci 2015;7:390-8.
96. Khaleel N, Rahaman SA. A validated stability indicating RP-HPLC method for simultaneous estimation of tenofovir disoproxil fumarate, cobicistat, emtricitabine and elvitegravir in bulk and pharmaceutical dosage form. Int J Pharm 2015;5:991-1002.
97. Komaroju D, Reddy GN, Dhanalakshmi K. Method development and validation for simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and tablet dosage form by using RP-HPLC. Int J Pharma Res Rev 2013;2:1-11.
98. Jagadabi V, Kumar PVN, Pamidi S, Ramaprasad LA, Pavani G. Identification and quantification of potential impurities using LC-PDA coupled with new qda mass detector in a new single tablet regimen containing dolutegravir, emtricitabine and tenofovir disoproxil fumarate tablets used in hiv-1 prevention. Int Res J Pharm 2019;10:91-104.
99. Kuna M, Dannana GS, Prasad SVUM. Development and validation of a new RP-HPLC method for simultaneous estimation of emtricitabine, tenofovir, cobicistat, elvitegravir and its comparision with a reported method. Indo Am J Pharm Sci 2017;4:1599-612.
100. Nagasarapu MR, Dannana GS. Development and validation of stability-indicating HPLC-DAD method for simultaneous determination of emtricitabine, elvetegravir, cobicistat and tenofovir in their tablet dosage forms. Indian J Pharm Edu Res 2016;50:205-11.
101. Saidulu P, Mastanamma SK, Suresh PV, Rani AP. Development and validation of stability-indicating HPLC-DAD method for simultaneous determination of emtricitabine, rilpivirine, and tenofovir alafenamide in bulk and their pharmaceutical dosage forms. Int J ChemTech Res 2018;11:329-39.
102. Nandini K, Muneer S, Sekhar KBC, Kiran BSS. Stability indicating RP-HPLC method development and validation for the quantification of tenofovir disoproxil fumarate in bulk and its dosage form. Int J PharmTech Res 2016;9:240-9.
103. Dubbaka A, Sireesha D, Bakshi V. Analytical method development and validation for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate by RP-HPLC method. MOJ Proteomics Bioinform 2016;4:306?9.
104. Sonawane PH, Panzade PS, Kale MA. Simultaneous estimation of lamivudine and tenofovir disoproxil fumarate in bulk and combined pharmaceutical dosage form by HPLC method. Asian J Biomed Pharm Sci 2013;3:27-30.
105. Saha C, Gupta NV, Chandan RS, Priya SP. Development of a validated stability indicating LC-MS method for the determination of tenofovir disoproxil fumarate using quality by design approach. Int J Appl Pharm 2019;11:406-17.
106. Babu C, Devanna N, Reddy KVNS. Validated gradient stability indicating RP-HPLC method for the simultaneous quantification of 11 related substances in the combined dosage forms of lamivudine and tenofovir disopeoxil fumarate. Int J Appl Pharm 2017;9:61-8.
107. Diana BH, Bibi SK, Kumari KS. New validated RP-HPLC method for simultaneous estimation of lamivudine and tenofovir disproxil fumarate in tablets. Int J Adv Pharm Anal 2015;5:10-3.
108. Havele S, Dhaneshwar SR. Development and validation of a stability-indicating LC method for the determination of tenofovir disoproxil fumarate in pharmaceutical formulation. Songklanakarin J Sci Technol 2012;34:615-22.
109. Ravisankar P, Mounika G, Devadasu CH, Rao GD. Novel analytical method development and validation for the quantitative analysis of efavirenz in bulk and pharmaceutical dosage forms by RP-HPLC. Pharma Innovation J 2014;3:32-9.
110. Gupta S, Kesarla R, Chotai N, Omri A. Development and validation of reversed phase HPLC gradient method for the estimation of efavirenz in plasma. PLoS One 2017;12:0174777.
111. Suneetha A, Bhavana G, Siddikha ASK. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of efavirenz, lamivudine, and stavudine in pharmaceutical dosage forms. BAOJ Pharm Sci 2017;3:41.
112. Viana OS, Medeiros FPM, Grangeiro Junior S, Albuquerque MM, Soares MFR. Development and validation of a HPLC analytical assay method for efavirenz tablets: a medicine for HIV infections. Brazilian J Pharm Sci 2011;47:97-102.
113. Kumar GS, Patnaik P, Patnaik A, Subrahmanyam KV. A new method development and validation of efavirenz by RP-HPLC. Int J Innovative Pharm Sci Res 2014;2:2962-70.
114. Waghmare SA, Kashid AM. Reverse phase-high performance liquid chromatography method development and validation for estimation of efavirenz by quality by design approach. J Drug Delivery Ther 2019;9:319-30.
115. Induri M, Mantripragada BR, Yejella RP. Development and validation of UPLC method for simultaneous estimation of Efavirenz and Lamivudine in pharmaceutical formulations. J Appl Pharm Sci 2016;6:29-33.
116. Bhavsar DS, Patel BN, Patel CN. RP-HPLC method for simultaneous estimation of tenofovir disoproxil fumarate, lamivudine, and efavirenz in combined tablet dosage form. Pharmaceutical Methods 2012;3:73-8.
117. Panchagiri S, Begum A, Valupadas C, Ciddi V. Quantitative bio-analysis of tenofovir disoproxil fumarate, lamivudine and efavirenz simultaneously in human plasma using reverse-phase liquid chromatography. Acta Sci Pharm Sci 2018;2:17-27.
118. Sumanth KS, Rao AS, Shankar DG. A new gradient RP-HPLC method development and validation for simultaneous estimation of lamivudine, tenofovir disoproxil fumarate and effavirenz in pharmaceutical dosage forms. Int J Pharm Chem Biol Sci 2018;8:195-203.
119. Maniyar UR, Koshe K, Katariya MV, Karva GS, Katariya VR, Jaiswal S. Stability indicating RP-HPLC method development and validation for the determination of potential degradation impurities of efavirenz, emtricitabine and tenofovir in combined pharmaceutical dosage form. Asian J Pharm Technol Innovation 2015;3:117-28.
120. Raju NA, Begum S. Simultaneous RP-HPLC method for the estimation of the emtricitabine, tenofovir disoproxil fumerate and efavirenz in tablet dosage forms. Res J Pharm Tech 2008;1:522-5.
121. Nirogi R, Bhyrapuneni G, Kandikere V, Mudigonda K, Komarneni P, Aleti R, et al. Simultaneous quantification of a non-nucleoside reverse transcriptase inhibitor efavirenz, a nucleoside reverse transcriptase inhibitor emtricitabine and a nucleotide reverse transcriptase inhibitor tenofovir in plasma by liquid chromatography positive ion electrospray tandem mass spectrometry. Biomed Chromatogr 2009;23:371–81.
122. Babu C, Rao LNK, Devanna N, Reddy SKVN. RP-UPLC method for the simultaneous quantification of related substances in emtricitabine, tenofovir disoproxil fumarate and efavirenz pharmaceutical dosage forms. J Chem Pharm Res 2017;9:45-52.
123. Rezaei M, Ramazani A, Hokmabadi F. Simultaneous estimation and validation of tenofovir disoproxil fumarate, emtricitabine and efavirenz by RP-HPLC method in combined tablet dosage form. Curr Pharm Anal 2019;15:561-7.
124. Sreelatha P, Devi BR. Development and validation of stability-indicating HPLC method for simultaneous estimation of tenofovir, emtricitabine and efavirenz in fixed dose combination drug product. Asian J Res Chem 2018;11:23-31.
125. Kumar KB, Ayele Y, Motbatnor B. A novel validated stability indacating method for simultaneous estimation of emtricitabine, tenofovir and efavirenz in tablet dosage form by RP-HPLC. Int J Med Pharm Res 2019;7:71-82.
126. Varma PSRCHNPD, Rao AL. Stability-indicating RP-HPLC method for the simultaneous estimation of efavirenz, tenofovir and emtricitabine in pharmaceutical formulations. Indian J Pharm Pharmacol 2014;1:1-19.
127. Tiwari P, Yadav R, Avinash KV, Vaidya PA, Sathe, Gangrade D. Development and validation of UPLC method for emtricitabine, tenofovir and efavirenz in pharmaceutical preparation. Anal Chem Indian J 2010;9:247-51.
128. Ashenafi D, Ungerbock M, Hoogmartens J, Adams E. Liquid chromatographic analysis of various formulations containing emtricitabine. Chromatographia 2013;76:1495–503.
129. Rao SA, Kumar NG, Srilekha K, Kumari AN. Stability indicating method for the simultaneous estimation of tenofovir, emtricitabine and efavirenz in pure and pharmaceutical dosage form by RP-HPLC. Int J Adv Res Sci Eng 2016;5:188-200.
130. Devrukhakar PS, Borkar R, Shastri N, Surendranath KV. A validated stability-indicating RP-HPLC method for the simultaneous determination of tenofovir, emtricitabine, and an efavirenz and statistical approach to determine the effect of variables. ISRN Chromatography 2013. https://doi.org/10.1155/2013/878295
131. Ramaswamy A, Arul AS, Dhas G. Development and validation of analytical method for quantitation of emtricitabine, tenofovir, efavirenz based on HPLC. Arabian J Chem 2018;11:275-81.
132. Sravanthi T, Madhavi N. Stability indicating UPLC method to quantify emtricitabine, tenofovir, and efavirenz simultaneously in tablets: method establishment. Int J Res Pharm Sci 2020;11:120-8.
133. Nadig S, Jacob JT, Bhat I, Kishoreraju V. A stability indicating RP-HPLC method for simultaneous estimation of Emtricitabine, Tenofovir disoproxil fumarate and Efavirenz in pharmaceutical dosage forms. Int J Res Pharm Sci 2013;4:391-6.
134. Badgujar BP, Mahajan MP, Sawant SD. Development and validation of RP-HPLC method for the simultaneous estimation of tenofovir alafenamide and emtricitabine in bulk and tablet dosage form. Int J Chem Tech Res 2017;10:731-9.
135. Panigrahy UP, Reddy AS. A novel validated RP-HPLC method for the simultaneous estimation of emtricitabine, tenofovir disoproxil fumarate and rilpivirine in bulk and pharmaceutical tablet dosage forms. Pharm Lett 2015;7:303-14.
136. Sayyed ZM, Sheikh AA, Shaikh ZA, Shinde SA. Development and validation of analytical method for simultaneous estimation of tenofovir and emtricitabine in pharmaceutical dosage forms by HPLC. Int J Pharm Drug Anal 2016;4:24-9.
137. Kavitha KY, Geetha G, Hariprasad R, Venkatnarayana R, Kaviarasu M. Development and validation of RP-UPLC analytical method for simultaneous estimation of emtricitabine, rilpivirine, tenofovir disoproxil fumarate and its pharmaceutical dosage forms. Int Res J Pharm 2013;4:150-5.
138. Yadav M, Singhal P, Goswami S, Pande UC, Sanyal M, Shrivastav PS. Selective determination of antiretroviral agents tenofovir, emtricitabine, and lamivudine in human Plasma by a LC-MS-MS method for a bioequivalence study in healthy Indian subjects. J Chromatographic Sci 2010;48:704-13.
139. Ahmad S, Rageeb M, Usman M. Analytical method development and validation for the simultaneous estimation of emtricitabine and tenofovir by reversed-phase high performance liquid chromatography in bulk and tablet dosage forms. Asian J Pharm Clin Res 2017;10:59-64.
140. Abdelhay MH, Gazy AA, Shaalan RA, Ashour HK. Selective RP-HPLC dad method for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets. Acta Chromatographica 2015;27:41–54.
141. Ashenafi D, Verbeek A, Hoogmartens J, Adams E. Development and validation of an LC method for the determination of emtricitabine and related compounds in the drug substance. J Sep Sci 2009;32:1823-30.
142. Delahunty T, Bushman L, Robbins B, Fletcher CV. The simultaneous assay of tenofovir and emtricitabine in plasma using LC/MS/MS and isotopically labeled internal standards. J Chromatography B 2009;877:1907-14.
143. Gomes NA, Vaidya VV, Pudage A, Joshi SS, Parekh SA. Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study. J Pharm Biomed Anal 2008;48:918-26.
144. Illamola SM, Valade E, Hirt D, Dulioust E, Zhengb Y, Wolfd JP, et al. Development and validation of a LC–MS/MS method for the quantification of tenofovir and emtricitabine in seminal plasma. J Chromatography B 2016;1033:234–41.
145. Venkateswararao B, Vidyadhara S, Nagaraju B, Jhonbi SK. A novel stability indicating RP-HPLC method development and validation for the determination of tenofovirdisoproxilfumarate and emtricitabine in bulk and pharmaceutical formulations. Int J Pharm Sci Res 2017;8:2168-76.
146. Mastanamma SK, Reddy VD, Saidulu P, Varalakhimi M. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of emtricitabine tenofovir alafenamide bulk and their combined dosage form. J Chem Pharm Res 2017;9:70-80.
147. Raju NA, Rao JV, Prakash KV, Mukkanti K, Srinivasu K. Simultaneous estimation of tenofovir disoproxil, emtricitabine and efavirenz in tablet dosage form by RP-HPLC. Orient J Chem 2008;24:645-50.
148. Cholke P, Chemate SZ, Joshi RS, Raskar MA, Sawant RL. Development and validation of spectrophotometric method for efavirenz in pure and in film coated tablet dosage form. Res J Pharm Technol 2011;4:1816-8.
149. Kumar P, Mittan DS, Kumar N. Development of UV spectroscopic method for the estimation of tenofovir in bulk and solid dosage forms. Anal Chem Indian J 2013;13:33-5.
150. Vidyadhara S, Sasidhar RLC, Rao BV, Kumari PR. Simultaneous UV spectrophotometric method for the determination of tenofovir, efavirenz and lamivudine in bulk and combined dosage form. Asian J Pharm Anal 2016;6:253-8.
151. Rajan RV. UV spectrophotometric estimation of emtricitabine by zero order and area under curve methods in bulk and pharmaceutical dosage form. Asian J Res Chem 2019;12:263-7.
152. Rajavel P. Analytical method development and validation of tenofovir by UV spectrophotometry. Asian J Res Pharm Sci Biotechnol 2016;4:88-94.
153. Srinath A, Sneha B, Alladi A, Ahmed R, Kulkarni RG. Method development and validation for simultaneous estimation of lamivudine, tenofovir and efavirenz in combined tablet dosage form by RP-HPLC and UV-spectroscopic method. Int J Pharm Sci Res 2014;5:5491-7.
154. Shelke A, Shinde M, Mogal R, Sable R, Jadhav A. Application of UV spectrophotometric methods for simultaneous estimation of emtricitabine and tenofovir alafenamide fumarate in bulk. Asian J Pharm Tech 2018;8:103-7.
155. Lavanya B, Hariprasad P, Venkatapraveen A, lakshmi DP, Dhanalakshmi. Method development and validation of combined tablet dosage form of emtricitabine and tenofovir disproxil fumerate by ultraviolet spectroscopy. Int Res J Pharm 2012;3:104-8.
156. Anandakumar K, Kannan K, Vetrichelvan T. Development and validation of emtricitabine and tenofovir disoproxil fumerate in pure and in fixed dose combination by uv spectrophotometry. Digest J Nanomaterials Biostructures 2011;6:1085-90.
157. Sri KV, Yadla DK, Shalem M, Sirisha VRK. Simultaneous estimation and validation of emtricitabine, tenofovir disproxil fumarate and efavirenz in pharmaceutical dosage form by UV-spectrophotometry. Chem Sci Rev Lett 2017;6:2581-9.
158. Harini U, Pawar AKM. Development and validation of stability indicating simultaneous uvspectrophotometric method for determination of emtricitabine, tenofovir disoproxil fumarate, cobicistat, and elvitegravir in pure and pharmaceutical dosage form. Asian J Pharm Clin Res 2018;11:177-84.
159. Nagaraju PT, Channabasavaraj KP, Shantha KPT. Development and validation of spectrophotometric method for estimation of emtricitabine in tablet dosage form. Int J ChemTech Res 2011;3:23-8.
160. Behera A, Parida A, Meher AK, Dannana GS, Moitra SK, Chandra SS. Development and validation of spectrophotometric method for determination of emtricitabine and tenofovir disoproxil fumarate in bulk and tablet dosage form. Int J PharmTech Res 2011;3:1874-82.
161. Shirkhedkar AA, Bhirud CH, Surana SJ. Application of uv-spectrophotometric methods for estimation of tenofovir disoproxil fumarate in tablets. Pak J Pharm Sci 2009;22:27-9.
162. Sharma R, Mehta K. Simultaneous spectrophotometric estimation of tenofovir disoproxil fumarate and lamivudine in three component tablet formulation containing efavirenz. Indian J Pharm Sci 2010;72:527-30.
163. Venkatesan S, Kannappan N. Simultaneous spectrophotometric method for determination of emtricitabine and tenofovir disoproxil fumarate in three-component tablet formulation containing rilpivirine hydrochloride. Int Scholarly Res Notices 2014. https://doi.org/10.1155/2014/541727
164. Ingale KD, Barhate AL, Kale AN, Bobade CD, Choudhari VP, Kuchekar BS. Spectrophotometric estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form by simultaneous equation and absorbance ratio methods. J Pharm Res 2010;9:11-3.
165. Choudhari VP, Ingale S, Gite SR, Tajane DD, Modak VG, Ambekar A. Spectrophotometric simultaneous determination of tenofovir disoproxil fumarate and emtricitabine in combined tablet dosage form by ratio derivative, first order derivative and absorbance corrected methods and its application to dissolution study. Pharm Methods 2011;2:47–52.
166. Ashour HK, Belal TS. New simple spectrophotometric method for determination of the antiviral mixture of emtricitabine and tenofovir Disoproxilfumarate. Arabian J Chem 2017;10:1741-7.
167. Dubbaka A, Sireesha D, Basha SA, Talla R, Haque MA, Harshini S, et al. Analytical method development and validation for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate in bulk and spectrophotometric method. Int J Innovative Pharm Sci Res 2015;3:1529–36.
168. Induri M, Mantripragada BR, Yejella RP. Development and validation of a HPTLC method for simultaneous estimation of efavirenz and lamivudine in pharmaceutical formulations. World J Pharm Sci 2016;4:189-94.
169. Pratima NA, Ajhar M, Shaikh O. HPTLC method development, validation for simultaneous determination of efavirenz, emtricitabine and tenofovir in combined tablet formulation and forced degradation studies. Am J PharmTech Res 2013;3:650-60.
170. Chitlange SS, Kanthale SB, Choudhary B, Bhole RP. Stability indicating HPTLC method for the simultaneous estimation of rilpivirin, emtricitabine and tenofovir in bulk and combined pharmaceutical dosage form. J Adv Drug Delivery 2014;1:157-72.
171. Chandra P, Rathore AS, Sathiyanarayanan L, Mahadik KR. Application of high performance thin-layer chromatographic method for the simultaneous determination of lamivudine and tenofovir disoproxil fumarate in pharmaceutical dosage form. J Chil Chem Soc 2011;56:702-5.
172. Kumar P, Dwivedi SC, Kushnoor A. Development and validation of HPTLC method for the determination of Efavirenz in bulk drug and tablet dosage form. Res J Pharm Biol Chem Sci 2011;2:160-8.
173. Shinde NV, Tompe PU, Damle MC, Madgulkar AR. Development and validation of HPTLC method for estimation of efavirenz in human plasma. J Chem Pharm Res 2013;5:85-90.
174. Mardia RB, Suhagia BN, Pasha TY, Chauhan SP, Solanki S. Development and validation of HPTLC method for estimation of tenofovir disoproxil fumarate in tablet dosage form. J Pharm Sci Biosci Res 2012;2:73-6.
175. Saminathan J, Vetrichelvan T. Development and validation of HPTLC method for simultaneous estimation of emtricitabine, rilpivirine and tenofovir disoproxil fumarate in combined dosage form. Bangladesh Pharm J 2016;19:114–21.
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MISHRA, R. K., CHAUBEY, N., PATEL, J. R., MISHRA, S., & SINGH, R. (2020). A REVIEW OF ANALYTICAL TECHNIQUES FOR DETERMINATION OF ANTI-HIV DRUGS. International Journal of Applied Pharmaceutics, 12(6), 41-50. https://doi.org/10.22159/ijap.2020v12i6.39040
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