ANALYTICAL METHODS FOR THE QUANTITATION OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM AND BIOLOGICAL FLUIDS

  • SK MANIRUL HAQUE Department of Chemical and Process Engineering Technology, Jubail Industrial College, P.O. Box No. 10099, Zip Code – 31961, Jubail Industrial City, Saudi Arabia.
  • MURAD ALSAWALHA Department of Chemical and Process Engineering Technology, Jubail Industrial College, P.O. Box No. 10099, Zip Code – 31961, Jubail Industrial City, Saudi Arabia.

Abstract

Amlodipine is the best-prescribed medication for cardiovascular disease major risk factor for hypertension and atorvastatin well known for diabetic. First discussed low cost ultraviolet-visible technique for the determination and quantitation of drugs in pharmaceuticals and biological fluids. Chromatographic techniques have an application with respect to trace analysis. Different types of chromatography such as high-performance liquid chromatography, high performance thin layer chromatography have most frequent applications in the field of pharmaceutical as well as biomedical analyses. Chromatography combined with mass spectrophotometry has the ability to collect molecular ion, followed to prepare a spectrum to assess molecular weight as well as structure. High-performance liquid chromatography coupled with mass spectrophotometry is a reliable and dynamic technique for the analysis of small and large drugs molecule. The advantages and disadvantages of all techniques are compared with each other with respect to sensitivity, reproducibility and other important parameters. The investigation also focused for the quantitation on both drugs in pharmaceutical preparations and plasma samples with the help of all available analytical techniques.

Keywords: Drugs, Amlodipine, Atorvastatin, HPLC, UPLC, TLC, HPTLC, CE, LCMS, UP-LCMS

References

1. Triggle DJ. Calcium channel antagonists: clinical uses-past, present and future. Biochem Pharmacol 2007;74:1-9.
2. Chmiel K, Knapik KJ, Jurkiewicz K, Sawicki W, Jachowicz R, Paluch M, et al. A new method to identify physically stable concentration of amorphous solid dispersions (I): case of Flutamide+Kollidon VA64. Mol Pharm 2017;14:3370–80.
3. Kumar DB, Patel J, Chhatoi P, Begum S, Dey S. Analytical method development and validation of amlodipine and benazepril hydrochloride in combined dosage form by RP-HPLC. Int J Chem Pharm Sci 2011;2:26–30.
4. Sun S, Wang R, Fan J, Zhang GQ, Zhang H. Effects of danshen tablets on pharmaco kinetics of atorvastatin calcium in rats and its potential mechanism. Pharm Biol 2018;56:104-8.
5. Garza L, Dols J, Gillespie M. An initiative to improve primary prevention of cardiovascular disease in adults with type II diabetes based on the ACC/AHA(2013) and ADA(2016) guidelines. J Am Assoc Nurs Pract 2017;29:606–11.
6. Lampropoulos K, Megalou A, Bazoukis G, Tse G, Manolis A. Pre-loading therapy with statins in patients with angina and acute coronary syndromes undergoing PCI. J Interv Cardiol 2017;30:507–13.
7. Cruz Correa OF, Leon Cachon RB, Barrera Saldana HA, Soberon X. Prediction of atorvastatin plasmatic concentrations in healthy volunteers using integrated pharmacogenetics sequencing. Pharmacogenomics 2017;18:121–31.
8. Dennison TJ, Smith JC, Badhan RK, Mohammed AR. Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability. Drug Des Dev Ther 2017;11:811–26.
9. Eng H, Scialis RJ, Rotter CJ, Lin J, Lazzaro S, Varma MV, et al. The antimicrobial agent fusidic acid inhibits organic anion transporting polypeptide–mediated hepatic clearance and may potentiate statin-induced myopathy. Drug Metab Dispos 2016;44:692–9.
10. Virani P, Sojitra R, Raj H, Jain V. A review on irbesartan co administered with atorvastatin for the treatment of cardiac risk. J Crit Rev 2014;1:25-8.
11. Abdulsalam FO, Prema KR, Asha IT. Spectrophotometric study oxidation of amlodipine besylate by chloramine-T in acidic buffer pH (4.3) medium. Der Pharma Chem 2018;10:67–73.
12. Raskar MA, Ganesh RG, Ashok BC, Pritam DG. Validated simultaneous spectrophotometric estimation of telmisartan, hydrochlorthiazide and amlodipine besylate in combined tablet dosage form. Der Pharm Lett 2015;7:120–4.
13. Srinivasulu P, Gowthami BK, Kumar TNVG, Raju DSN, Vidyadhara S. Determination of amlodipine in rat plasma by uv spectroscopy. Indo Global J Pharma Sci 2015;5:205–9.
14. Naveed S, Hina Q, Wardha J, Urooj B. Simple UV spectrophotometric assay of amlodipine. Am J Chem Appl 2014;1:66–9.
15. Manisha M, Abhilasha M, Nandy BC. Spectrophotometric simultaneous estimation of amlodipine besylate and losartan potassium in tablet dosage forms. Asian J Pharm Clin Res 2014;7:61–3.
16. Nina A, Fatimeh H. Spectrophotometric method for the determination of amlodipine besylate in pure and dosage forms using 7,7,8,8-tetracyanoquinodimethane and tetracyanoethylene. Bull Faculty Pharm Cairo Univ 2014;52:109–14.
17. Rajesh BHV, Praveen KJ, Raveendra GB, Sri PLS, Praveen TK, Rao PS. UV spectroscopic method for estimation of amlodipine besylate in tablets. Int J Pharm Chem Bio Sci 2014;4:69–73.
18. Samixa PR, Patel CN. Development and validation of spectrophotometric method for determination of aliskiren, amlodipine and hydrochlorothiazide in combined pharmaceutical dosage forms. Asian J Pharm Anal 2014;4:166–71.
19. Pawar PY, Mane BY, Sumit MA, Vipul VT. Simultaneous estimation of amlodipine besylate and atenolol in combined dosage form by Vierodt’s method using U. V. spectroscopy. Der Pharma Chem 2013;5:97-102.
20. Laxmileena DP, Sachin VG, Deepali DJ, Yogita AK, Sampada DD, Pramod LI. Development and validation of UV–spectrophotometric methods for simultaneous estimation of amlodipine besylate and clopidogrel bisulfate in bulk and tablet dosage form. Der Pharma Chem 2013;5:282–7.
21. Mahmoud RS, Parviz A, Maryam D. Simultaneous quantitative determination of amlodipine and atorvastatin in tablets using artificial neural networks. Math Com Modell 2013;58:1588–94.
22. Varsha RG, Baheti KG, Indraksha S, Dehghan MH. Estimation of amlodipine besylate, valsartan and hydrochlorothiazide in bulk mixture and tablet by UV spectrophotometry. Indian J Pharm Sci 2012;74:18-23.
23. Kondawar MS, Kamble KG, Raut KS, Maharshi KH. UV Spectrophotometric estimation of amlodipine besylate and telmisartan in bulk drug and dosage form by multi wavelength analysis. Int J Chem Tech Res 2011;3:1274–8.
24. Smita TK, Swapnil DJ, Neela MB, Manish SB. Development and validation of derivative spectrophotometric method for estimation of atorvastatin calcium and amlodipine besylate in tablet dosage form. Int J Pharm Pharm Sci 2011;3 Suppl 4:195–7.
25. Pandurang ND, Sunita RB. Simultaneous UV spectrophotometric methods for estimation of amlodipine besilate and olmesartan medoxomil in tablet dosage form. J Chem Pharm Res 2011;32:650–6.
26. Shyni B, Molly M, Senthilkumar KL. Spectrophotometric method of estimation of amlodipine besylate using hydrotropic solubilization. J Appl Pharm Sci 2011;1:177–80.
27. Gayathri S, Devi TSR, Gunasekaran S. Qualitative and quantitative analysis on some cardiovascular drugs. Asian J Chem 2010;22:5824–34.
28. Kardile DP, Kalyane NV, Thakkar TH, Patel MR, Moradiya RK. Simultaneous estimation of amlodipine besylate and olmesartan medoxomil drug formulations by HPLC and UV-spectrophotometric methods. J Pharm Sci Res 2010;2:599–614.
29. Bilal Y, Selcuk K. UV and first derivative spectrophotometric methods for the estimation of atorvastatin in pharmaceutical preparations. J Adv Pharma Res 2018;2:89–94.
30. Sobhy MAA, Lobna MAA, Maha AMM. Spectrophotometric determination of atorvastatin calcium and rosuvastatin calcium in bulk and dosage form using p-dimethylaminobenzaldehyde. J Appl Pharm 2017;9:233.
31. Alshabrawy A, Ahmed M, Nageh A. Sensitive spectrophotometric determination of atorvastatin in pharmaceutical formulation by ion pair complexation with pararosaniline hydrochloride. J Adv Pharma Res 2017;1:193–200.
32. Ramadan AA, Hasna M, Jenan S. Determination of atorvastatin calcium in pure and its pharmaceutical formulations using iodine in acetonitrile by uv-visible spectrophotometric method. Int J Pharm Pharm Sci 2015;7:427-33.
33. Jadhav NR, Ramesh SK, Sameer JN. Dual wavelength spectrophotometric method for simultaneous estimation of atorvastatin calcium and felodipine from tablet dosage form. Adv Chem 2014;6. http://dx.doi.org/10.1155/2014/131974
34. Suresh JNK, Babu CN, Dhanalakshmi T, Florence K, Ramanjaneyulu MS, Sambasivanaik N. Development and validation of spectrophotometric method for estimation of atorvastatin calcium bulk and pharmaceutical formulations. World J Pharma Pharm Sci 2014;3:1305–13.
35. Safila N. Simple uv spectrophotometric assay of atorvastatin API formulation and their comparative study. Global J Med Res: B Pharm Drug Discovery Toxi Med 2014;14:34–8.
36. Kailash PP, Bhandari A. Spectroscopic method for estimation of atorvastatin calcium in tablet dosage form. Indo Global J Pharma Sci 2011;1:294–9.
37. Swapnil DJ, Manish SB, Shivaji LT, Sachin AP. Spectrophotometric methods for estimation of atorvastatin calcium form tablet dosage forms. Int J Pharm Tech Res 2010;2:1948-53.
38. Sandeep SS, Atul AS, Ravindra AF, Sanjay JS. Application of UV-spectrophotometry and RP-HPLC for simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical dosage form. Eurasian J Anal Chem 2006;1:31–41.
39. Dhiraj K, Susanta KP, Sudhir KS. Development of stability indicating RP-HPLC method for simultaneous estimation of amlodipine and olmesartan in pure and pharmaceutical dosage form. Int J Pharm Sci Drug Res 2018;10:379–85.
40. Bhagyalaxmi C, Sahoo SK, Kavitha D, Nagamani M, Lagnajit M. Development and validation of new analytical RPHPLC method for the estimation of amlodipine and perindopril in tablet dosage form. Int J Pharma Res Health Sci 2018;6:2433–36.
41. Vidhi AM. RP-HPLC method development and validation for simultaneous estimation of irbesartan, amlodipine besylate and hydrochlorothiazide in tablet. World J Pharm Res 2018;7:690–701.
42. Abhi K, Manju M. Development and validation of RP-HPLC and UV-spectrophotometric methods for rapid simultaneous estimation of amlodipine and benazepril in pure and fixed dose combination. Arabian J Chem 2017;10:S3021–8.
43. Ariadne MB, Jerusa SG, Marcello GT. Development and validation of a chromatography method using tandem UV/charged aerosol detector for simultaneous determination of amlodipine besylate and olmesartan medoxomil: application to drug-excipient compatibility study. J Anal Methods Chem 2017;Vol 2017:8. https://doi.org/10.1155/2017/4878316
44. Osman RAM, Elbashir AA. Development and validation of stability indicating HPLC method for the simultaneous analysis of amlodipine, hydrochlorothiazide and valsartan in pharmaceutical formulation, J Anal Pharm Res 2017;6:00188.
45. Rasha AS, Tarek SB, Fawzy AEY, Sohila ME. Validated stability-indicating HPLC-DAD method of analysis for the antihypertensive triple mixture of amlodipine besylate, valsartan and hydrochlorothiazide in their tablets. Arabian J Chem 2017;10:S1381–94.
46. Gunasekar M. Simultaneous determination and estimation of amlodipine and perindopril in raw and tablet formulation by stability indicating RP-HPLC method. IOSR J Pharma Biol Sci 2016;11:24–9.
47. Chamarthi RPK, Mohan GVK. Development and validation of amlodipine impurities in amlodipine tablets using design space computer modeling. Am J Anal Chem 2016;7:918–26.
48. Hassan SA, Elzanfaly ES, El-Zeany SB, Salem MY. Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets. Acta Pharm 2016;66:479–90.
49. Mounika P, Rani PJ, Pranathi G, Haque MA, Sireesha D, Harshini S, et al. Development and validation of RP-HPLC method for the simultaneous estimation of amlodipine and metoprolol in bulk and pharmaceutical dosage form. Indo Am J Pharm Res 2015;5:3254–60.
50. Hafez HM, Elshanawany AA, Abdelaziz LM, Mohram MS. Development of a stability-indicating HPLC method for simultaneous determination of amlodipine besylate and atorvastatin calcium in tablets. Austin J Anal Pharm Chem 2014;1:11.
51. Manish S, Charmy K, Omkar S, Priti M. Concurrent estimation of amlodipine besylate, hydrochlorothiazide and valsartan by RP-HPLC, HPTLC and UV–spectrophotometry. J Chromatogr Sci 2014;52:27–35.
52. Bharti AR, Deshmane SV, Biyani KR. Stability indicating RP-HPLC method for development and validation for simultaneous estimation of amlodipine and hydrochlorothiazide in pharmaceutical dosage form. Int J Curr Pharm Res 2014;6:16-9.
53. Anandkumar RT, Gurupadayya BM, Soni N. Simultaneous estimation of hydrochlorothiazide, amlodipine, and losartan in tablet dosage form by RP-HPLC. Int J Chem Anal Sci 2013;4:33–8.
54. Samya MEG, Abdelmageed OH, Omar MA, Deryea SM, Abdel Megied AM. Development and validation of HPLC method for simultaneous determination of amlodipine, valsartan, hydrochlorothiazide in dosage form and spiked human plasma. Am J Anal Chem 2012;3:422–30.
55. Karunakar N, Puranik SB, Kumar GVS, Masood MD, Sridhar KA. Development and validation of RP-HPLC method for simultaneous estimation of amlodipine and indapamide in bulk and tablet dosage form. Asian J Biomed Pharm Sci 2012;2:55–9.
56. Kayal SD, Khan FA, Tated AG, Bakal RL, Chandewar AV. Method development and validation for the simultaneous determination of amlodipine besylate and telmisartan in tablet dosage form by RP-HPLC. Int J Pharm Res Dev 2011;3:144–53.
57. Pournima SP, More HN, Pishwikar SA. RPHPLC method for simultaneous estimation of amlodipine besylate and olmesartan medoxomil from tablet. Int J Pharm Pharm Sci 2011;3 Suppl 3:146–9.
58. Hassan AA, Alnami AM, Arishi MAA, Alameer RK, Bratty MA, Rehman ZU, et al. A fast and validated reversed-phase HPLC method for simultaneous determination of simvastatin, atorvastatin, telmisartan and irbesartan in bulk drugs and tablet formulations. Sci Pharm 2018;86:1.
59. Rao S, Balaswami B, Ramana PV, Sanjeeva P, Srenivasulareddy G. New stability-indicating RP-HPLC-PDA method for simultaneous estimation of triplicate mixture of ramipril, atorvastatin and clopidogrel in tablet dosage form. Int J Appl Pharm 2018;10:90-6.
60. Azmi SNH, Al-Mamari AK, Al-Hosni BS, Al-Fazari MR. High performance liquid chromatographic-UV method for determination of atorvastatin calcium in pharmaceutical formulations. J New Dev Chem 2017;1:38–50.
61. Yusuf SM, Samparna S, Yallareddy K, Pavani B, Sivakala T. Analytical method development and validation of atorvastatin and clopidogrel in tablet dosage form by RP-HPLC. Eur J Pharma Med Res 2017;4:553-8.
62. Jaiprakash NS, Mohammed A, Zahid Z, Ahmed RZ, Dehghan MHG, Gonjari I. Development and validation of RP-HPLC method for determination of atorvastatin calcium and nicotinic acid in combined tablet dosage form. J Saudi Chem Soc 2016;20:S328–33.
63. Rudwan EH, Mohammed ABWE, Saeed AEM. A new RP-HPLC method for quantitative analysis of atorvastatin calcium in bulk and pharmaceutical dosage form by using design of experiment technique optimization. Int Res J Pure Appl Chem 2016;13:10.
64. Patil PM, Bobade AS. Development and validation of stability indicating RP-HPLC for determination of atorvastatin calcium and ezetimibe in bulk and pharmaceutical dosage forms. Int J Pharm Pharm Sci 2016;8:38–42.
65. Khaleel N, Rahaman SA. Validated stability indicating RP-HPLC method for simultaneous determination of atorvastatin, fenofibrate and folic acid in bulk and pharmaceutical dosage form. Der Pharm Lett 2016;8:13–32.
66. Patil PM, Bobade AS. Development and validation of stability indicating RP-HPLC for determination of atorvastatin calcium and ezetimibe in bulk and pharmaceutical dosage forms. Int J Pharm Pharm Sci 2016;8:38-42.
67. Rudwan EH, Hussien ABWEM, Saeed AEM. Development and validation of stability indicating high performance liquid chromatography method for determination of atorvastatin calcium in the presence of its degradation products. Der Pharma Sin 2015;6:19–27.
68. Octavian C, Spiridon AM, Belu I, Ftiolics AT, Neamuu J. Development and validation of an HPLC method for simultaneous quantification of clopidogrel bisulfate, its carboxylic acid metabolite, and atorvastatin in human plasma: application to a pharmacokinetic study. J Anal Methods Chem 2015;12. http://dx.doi.org/10.1155/2015/892470
69. Swamy GK, Rao JVLNS, Kumar JMR. New stability indicating validated RP-HPLC method for simultaneous estimation of irbesartan and atorvastatin in combined tablet dosage forms. Am J Pharm Tech Res 2015;5:380–9.
70. Simionato LD, Ferello L, Stamer SG, Repetto MF, Zubata PD, Segall AI. A validated reversed-phase HPLC method for the determination of atorvastatin calcium in tablets. Austin Chromatogr 2014;1:4.
71. Mallesh K, Sobahi TR, Helw AME, Abdelaal MY. Development and validation of a RP-HPLC method for assay of atorvastatin and its application in dissolution studies on thermosensitive hydrogel-based nanocrystals. Trop J Pharm Res 2014;13:1681–7.
72. Ramesh D, Habibuddin M, Dash RN, Humaira T. Simultaneous determination of atorvastatin calcium and losartan potassium in bulk and combined dosage forms by validated RP-HPLC with UV detection. Am J Pharm Tech Res 2013;31:675–85.
73. Bhinge SD, Malipatil SM, Jondhale A, Hirave R, Savali AS. A new approach to the RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in pharmaceutical dosage forms. E J Chem 2012;9:1223–9.
74. Ganesh M, Hemalatha P, Sakthimanigandan K, Mei PM, Lee SG. Simultaneous estimation of atorvastatin and ezetimibe in combined formulation by RP-HPLC. Asian J Chem 2012;24:1867–71.
75. Kumar P, Ghosh A, Chaudhary M. Stability indicating method development for simultaneous estimation of ezetimibe and atorvastatin in pharmaceutical formulations by RP-HPLC. Pharm Anal Acta 2012;3:164.
76. Charde MS, Gupta A, Chakole RD. Determination of atorvastatin calcium in pharmaceutical formulations by reverse phase-high performance liquid chromatography. Int J Adv Pharm Anal 2011;1:48–53.
77. Rupali H, Bendagude R, Kondawar M. RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. J Pharma Res 2010;3:2400-1.
78. Mustafa G, Azeem A, Ahmad FJ, Khan ZI, Shakeel F, Talegaonkar S. Stability-indicating RP-HPLC method for analysis of atorvastatin in bulk drug, marketed tablet and nano emulsion formulation. J Chil Chem Soc 2010;55:184–8.
79. Jain N, Raghuwanshi R, Jain D. Development and validation of RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. Indian J Pharm Sci 2008;70:263–5.
80. Seshachalam U, Kothapally CB. HPLC analysis for simultaneous determination of atorvastatin and ezetimibe in pharmaceutical formulations. J Liq Chromatogr Relat Tech 2008;31:714–21.
81. Shah DA, Bhatt KK, Mehta RS, Shankar MB, Baldania SL, Gandhi TR. Development and validation of a RP-HPLC method for determination of atorvastatin calcium and aspirin in a capsule dosage form. Indian J Pharm Sci 2007;69:546–9.
82. Stanisz B, Lukasz K. Validation of HPLC method for determination of atorvastatin in tablets and for monitoring stability in solid phase. Acta Poloniae Pharm Drug Res 2006;63:471–6.
83. Sidika E, Aktas ES, Ersoy L, Ficicioglu S. An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J Pharm Biomed Anal 2003;33:1017–23.
84. Bharti T, Richa S. Development of short and robust analytical method on UPLC-MS for quantitative estimation of different API’s in their formulated products–a green analytical chemistry approach. Eur J Biomed Pharm Sci 2017;4:405–17.
85. Balakrishnan A, Vijay AR, Senthilkumar N, Gangadevi N. Analytical method development and validation of amlodipine–an antihypertensive and chlorthalidone–a thiazide diuretic by RP-UPLC method. Int J Chem Pharm Sci 2016;7:12–7.
86. Hanan AM, Nesrin KR, Sherine SD, Azza AM. Development and validation of UPLC methods for simultaneous determination of selected antihypertensive drugs in their dosage forms. Int J Adv Sci Eng Tech 2015;3:45–50.
87. Patel KN, Patel NB, Sevak MR, Desai HT. Development and validation of RP-UPLC method for simultaneous estimation of amlodipine and indapamide in their combined tablet dosage form. J Pharm Sci Bio Sci Res 2015;5:101–9.
88. Waghmare AN, Muddukrishna BS, Vasantharaju SG. Analytical method development and validation of simultaneous estimation of amlodipine and atorvastatin by RP-UPLC. Mintage J Pharm Med Sci 2014;3 Suppl 2:22–5.
89. Mallikarjuna S, Ramalingam P, Sriram P, Garima J, Srinivas SK. Development and validation of stability indicating RP-UPLC method for simultaneous estimation of amlodipine besylate and atorvastatin calcium in pharmaceutical dosage forms. J Chromatogr Sep Tech 2013;4:187.
90. Santaji N, Vangala RR, Rao DD, Rao IK. Rapid simultaneous determination of telmisartan, amlodipine besylate and hydrochlorothiazide in a combined poly pill dosage form by stability-indicating ultra-performance liquid chromatography. Sci Pharm 2011;79:69–84.
91. Lakshmi NYS, Barhate VD. Development and validation of stability indicating UPLC method for the simultaneous determination of beta-blockers and diuretic drugs in pharmaceutical dosage forms. J Chem Metrol 2010;4:1–20.
92. Lakshmi KS, Seetharaman R. Design and study of reverse phase ultra-high performance liquid chromatographic method for simultaneous estimation of two antidiabetic drugs with an antihyperlipemic drug using statistical approach. Int J Pharm Pharm Sci 2014;6:257–62.
93. Darwish MK, Manal MF, Zaazaa HE, Razeq SAA, Zeinab AN. Formulation, optimization and simultaneous determination of atorvastatin calcium and losartan potassium in pure and bilayer tablets, J Global Trends Pharm Sci 2014;5:1756–68.
94. Goel A, Sanjula B, Jasjeet KS, Kona SS, Ravi SG, Gupta A, et al. Development and validation of stability-indicating assay method by UPLC for a fixed dose combination of atorvastatin and ezetimibe. J Chromatogr Sci 2013;51:222–8.
95. Kakumani KK, Rao CK, Lakshmi MV, Mukkanti K. A validated stability indicating RP-UPLC method for atrovastain calcium. Am J Anal Chem 2012;3:392–9.
96. Kaila HO, Ambasana MA, Shah AK. A simple and rapid ultra-performance liquid chromatographic assay method for the simultaneous determination of aspirin, clopidogrel bisulphate and atorvastatin calcium in capsule dosage form. Int J Chem Tech Res 2011;3:459–65.
97. Shetty SK, Surendranath KV, Radhakrishnanand P, Borkar RM, Devrukhakar PS, Johnson J, et al. Stress degradation behavior of a polypill and development of stability indicating UHPLC method for the simultaneous estimation of aspirin, atorvastatin, ramipril and metoprolol succinate. Am J Anal Chem 2011;2:401–10.
98. Seshadri RK, Desai MM, Raghavaraju TV, Krishnan D, Rao DV, Chakravarthy IE. Simultaneous quantitative determination of metoprolol, atorvastatin and ramipril in capsules by a validated stability indicating RP-UPLC method. Sci Pharm 2010;78:821-34.
99. Abdul AR, Hussen AA, Mohammad M. TLC simultaneous determination of amlodipine, atorvastatin, rosuvastatin and valsartan in pure form and in tablets using phenyl-modified aleppo bentonite. Int J Pharm Pharma Sci 2014;6:180–8.
100. Shirkhedkar A, Surana S. Simultaneous densitometric TLC analysis of atorvastatin calcium and fenofibrate in the bulk drug and in pharmaceutical formulations. J Plan Chromatogr Mod TLC 2009;22:355–8.
101. Nikalje AG, Choudhari VP. Validated TLC method for simultaneous quantitation of atorvastatin, ezetimibe, and fenofibrate in bulk drug and formulations. Acta Chromatogra 2011;23:267–80.
102. Logoyda L, Korobko D, Saprun S. Development of methods for identification of calcium channel blockers in medicines. Int J Res Ayurved Pharm 2016;7:88–91.
103. Sonia K, Manikandan K, Hamunyare N, Peddamadi BS, Lakshmi KS. Method development and validation of simultaneous estimation for amlodipine besylate and olmesartan medoxomil by HPTLC method. Int J Res Pharm Sci 2018;9:201–5.
104. Rao NM, Sankar DG. Development and validation of HPTLC method for the simultaneous estimation of amlodipine besylate and atorvastatin calcium in combined dosage form. Eurasian J Anal Chem 2016;11:155–68.
105. Marolia BP, Bodiwala KB, Shah SA, Prajapati PB, Satani BH, Desai SA. Development and validation of HPTLC method for simultaneous estimation of amlodipine besylate, hydrochlorothiazide and telmisartan in their combined tablet dosage form. Pharm Methods 2016;7:48–53.
106. Shah DA, Patel DV, Mehta FA, Chhalotiya UK, Bhatt KK. High-performance thin-layer chromatography method for estimatingthe stability of a combination of irbesartan and amlodipine besylate. J Taibah Univ Sci 2015;9:177–86.
107. Sindhav JR, Chhalotiya UK, Shah DA, Mehta FA, Bhatt KK. Stability-indicating HPTLC method for simultaneous quantification of moxonidine and amlodipine besylate in their combined pharmaceutical dosage form. Austin Chromatogr 2015;2:1031, 7.
108. Jain PS, Patel MK, Surana SJ. Development and validation of HPTLC method for simultaneous determination of amlodipine besylate and metoprolol succinate in bulk and tablets. Indian J Pharm Sci 2012;74:152–6.
109. Kothapalli LP, Panchaware MS, Nanda RK, Thomas AB. Stability-indicating HPTLC method for simultaneous determination of lisinopril anhydrate and s-amlodipine besylate in pharmaceutical dosage form. Asian J Res Chem 2012;5:1061–6.
110. Deshmukh TB, Deo SS. Development and validation of novel HPTLC method for the simultaneous estimation of atorvastatin calcium and telmisartan in tablet dosage form. Int J Pharm Chem Biol Sci 2018;8:82–90.
111. Misari PK, Ezhava SB. Development and validation of HPTLC method for simultaneous estimation of atorvastatin calcium and vitamin d3 in pharmaceutical dosage form. World J Pharm Sci 2014;2:1511–9.
112. Kolsure AK, Chavan BB, Chabukswar AR, Kuchekar BS. Development and validation of a HPTLC method for simultaneous estimation of atorvastatin calcium and losartan potassium in combined dosage form. J Med Pharm Innov 2014;1:21–5.
113. Kaliappan I, Kumar PSS. Development and validation of stability indicating HPTLC and HPLC methods for simultaneous determination of telmisartan and atorvastatin in their formulations. J Chem 2013. http://dx.doi.org/10.1155/ 2013/725385.
114. Ginoya CG, Thakkar DV. Development and validation of HPTLC method for simultaneous determination of metoprolol succinate and atorvastatin calcium in a pharmaceutical dosage form. Int Res J Pharma 2013;4:102–7.
115. Wankhede SB, Dixit NR, Chitlange SS. Stability indicating HPTLC method for quantitative determination of atorvastatin calcium and metoprolol succinate in capsules. Der Pharmacia Lett 2011;3:1–7.
116. Mohamed MH, Maha S, Haya AJ. Development of capillary electrophoresis technique for simultaneous measurement of amlodipine and atorvastatin from their combination drug formulations. J Liq Chromatogr Relat Technol 2009;32:2923–42.
117. Alshehri MM. A validated capillary electrophoresis method for simultaneous determination of ezetimibe and atorvastatin in pharmaceutical formulations. Saudi Pharm J 2012;20:143–8.
118. Eleonora M, Teodora B, Gabriel H, Valentin I, Anca C. Simultaneous determination of amlodipine and atorvastatin by capillary electrophoresis from fixed pharmaceutical formulations. Farmacia 2016;64:398–402.
119. Said AH, Eman SE, Maissa YS, Badr AEZ. Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets. Acta Pharm 2016;66:479–90.
120. Modroiu A, Hancu G, Vlad RA, Stacescu S, Soare R, Kelemen H. Simultaneous determination of amlodipine and telmisartan from pharmaceutical products by way of capillary electrophoresis. Curr Issues Pharm Med Sci 2016;29:42–5.
121. Mahesh A, Adbullah B, Hussain MB. Capillary electrophoresis method development for simultaneous determination of atorvastatin and ezetimibe from solid dosage form. J Young Pharm 2017;9:122–5.
122. Blanka SS, Gabriel H, Istvan SS, Bela K, Hajnal K. Simultaneous determination of atorvastatin and ezetimibe from combined pharmaceutical products by micellar electrokinetic capillary chromatography. Braz J Pharm Sci 2017;53:e16122.
123. Wanga L, Liua W, Zhanga Z, Tiana Y. Validated LC–MS/MS method for the determination of amlodipine enantiomers in rat plasma and its application to a stereo selective pharmacokinetic study. J Pharm Biomed Anal 2018;158:74–81.
124. Haque AM, Priya SDK, Mohanty D, Bakshi V, Boggula N. Analytical method development and validation of amlodipine in human plasma using liquid chromatography-mass spectrometry/mass spectrometry. Asian J Pharm Clin Res 2018;11:393–7.
125. Shah JV, Parekh JM, Shah PA, Shaha PV, Sanyal M, Shrivastav PS. Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study. J Pharm Anal 2017;7:309-16.
126. Hossein D, Hamidi M. Method validation of amlodipine and atorvastatin by liquid chromatography–mass spectrometry (LC–MS) method in human plasma. Cogent Med 2016;3:1129790.
127. Alvi SN, Hussein RF, Dgither SA, Hammami MM. Quantitation of amlodipine in human plasma by LCMS/MS assay. Int J Pharm Pharm Sci 2016;8:268-72.
128. Jangala H, Vats P, Khuroo AH, Monif T. Development and validation of a LC-MS/MS method for the simultaneous estimation of amlodipine and valsartan in human plasma: application to a bioequivalence study. Sci Pharm 2014;82:585–600.
129. Shankar GG, Deme P, Kuncha M, Sistla R. Simultaneous determination of amlodipine, valsartan and hydrochlorothiazide by LC-ESI-MS/MS and its application to pharmacokinetics in rats. J Pharm Anal 2014;4:399-406.
130. Chan ML, Wei CM, Bu FL, Chen R, Wang XL, Li R, et al. Determination of amlodipine in human plasma by LC-MS/MS and its bioequivalence study in healthy chinese subjects. Pharmacol Pharma 2013;4:191–200.
131. Sakac MC, Vujic Z, Vujcic Z, Markovic B, Vasiljevic D. LC–MS/MS method for quantification of atorvastatin, o-hydroxyatorvastatin, p-hydroxyatorvastatin, and atorvastatin lactone in rat plasma. Acta Chromatogr 2016;28:281-98.
132. Jiang W, Luzum JA, Phelpsa MA, Kitzmiller JP. Liquid chromatography–tandem mass spectrometry assay for the simultaneous quantification of simvastatin, lovastatin, atorvastatin, and their major metabolites in human plasma. J Chromatogr B 2015;983–984:18–25.
133. Partani P, Verma SM, Gurule S, Khuroo A, Monif T. Simultaneous quantitation of atorvastatin and its two active metabolites in human plasma by liquid chromatography/(–) electrospray tandem mass spectrometry. J Pharm Anal 2014;4:26–36.
134. Ramzia IEB, Elkady EF, Sherif ZAE, Kadry AM. LC–MS–MS simultaneous determination of atorvastatin and ezetimibe in human plasma. J Chromatogr Sci 2014;52:773–80.
135. Gajula R, Pilli NR, Ravi VB, Maddela R, Inamadugu JK, Polagani SR, Busa S. Simultaneous determination of atorvastatin and aspirin in human plasma by LC–MS/MS: its pharmacokinetic application. Sci Pharm 2012;80:923–40.
136. Ashutosh JJ, Dasandi B, Rathnam S, Mehta AA. Liquid chromatographic-MS/MS determination of atorvastatin and metabolites in human plasma. Eurasian J Anal Chem 2010;5:46–52.
137. Kalaiyarasi D, Jaganathan KS, Krishna MV. Bioanalytical method validation for perindopril and amlodipine in human plasma using UPLC/ESI-MS/MS. World J Pharm Res 2018;7:1567–80.
138. Ahmed M, Alshabrawy A, Nageh A. UPLC-MS/MS method for kinetic studies and simultaneous determination of amlodipine and atorvastatin in bulk, and their combined dosage form. Anal Chem Ind J 2016;16:102.
139. Walid ME, Elkady EF, Zaher AAE, Bagary RIE, Patonay G. Simultaneous determination of aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide in spiked human plasma using UPLC-MS/MS. J Chromatogr Sci 2015;53:1178–84.
140. Xia B, Li Y, Zhang Y, Xue M, Li X, Xu P, et al. UHPLC-MS/MS method for determination of atorvastatin calcium inhuman plasma: application to a pharmacokinetic study based on healthy volunteers with specific genotype. J Pharm Biomed Anal 2018;160:428–35.
141. Liyun C, Zhijie Z, Xipei W, Lan T, Liping M, Guodong H, et al. Simultaneous determination of atorvastatin and its metabolites in human plasma by UPLC-MS/MS. Anal Methods 2017;9:1038–45.
142. Lucie N, Hana V, Dalibor S, Petr S, Dagmar S, Milan B, et al. Ultrahigh performance liquid chromatography tandem mass spectrometric detection in clinical analysis of simvastatin and atorvastatin. J Chromatogr B 2009;877:2093–103.
Statistics
342 Views | 215 Downloads
Citatons
How to Cite
HAQUE, S. M., & ALSAWALHA, M. (2019). ANALYTICAL METHODS FOR THE QUANTITATION OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM AND BIOLOGICAL FLUIDS. International Journal of Applied Pharmaceutics, 11(3), 5-15. https://doi.org/10.22159/ijap.2019v11i3.32566
Section
Review Article(s)