ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF SOME ACTIVE PHARMACEUTICAL INGREDIENTS FROM THE GROUP OF ANGIOTENSIN CONVERTING ENZYME INHIBITORS IN DRUGS AND BIOLOGICAL LIQUIDS
The quantity of medication brought into the marketplace is growing each year. Analytical method development is increasingly being introduced into fundamental pharmaceutical research and pharmaceutical analysis practice, taking into account their high sensitivity, accuracy, specificity and expressiveness. Search criteria was analytical method development for medicines from group of ACE inhibitors. Literature survey has been done in range of years 1990-2018 to make the review updated and comprehensive and to show the new approacheches to the development of the methods of analysis ACE inhibitors. The sources were world recognized journals and key words used as filter were angiotensin-converting enzyme inhibitors, captopril, enalapril, method development, spectrophotometry, HPLC, UHPLC. The current review is created with an intended to focus on the advantage of HPLC. Literature survey revealed that a number of methods have been reported for estimation of ACE inhibitors individually or in combination with other drugs. However, there is very few analytical methods reported for the simultaneous analysis of these drugs in a combined dosage formulation by HPLC. In additional, analysis of approaches to the development of the methods of analysis of ACE inhibitors in drugs and biological liquids has been shown that HPLC is the most suitable method for analyses ACE inhibitors in substances, drugs, biological liquids to performe routine analysis of medicines, pharmacokinetic (bioequivalence in vivo), dissolution test for final dosages forms (bioequivalence in vitro, biowaiver procedure).
2. https://pubchem.ncbi.nlm.nih.gov/compound/44093#section=Drug-and-Medication-Information [Last accessed on 01 Jan 2019].
3. El-Ashry SM, Ibrahim FA. Colorimetric determination of captopril in dosage forms. Anal Lett 1992;25:1657–72.
4. Ashour FM, Salama FM, Aziza MAE. A colorimetric method for the determination of captopril. J Drugs Res 1990;19:323–6,
5. Jovanivic T, Stanovic B, Koricanac Z. Spectrophotometric investigation on complex-formation of captopril with palladium (II) and its analytical application. J Pharm Biomed Anal 1995;13:213–7.
6. Dawood HM, Intesar AS, Hend A. Spectrophotometric method for the determination of captopril in pharmaceutical formulations. Baghdad Sci J 2013;10:965–70.
7. Sanghavi NM, Samarth MM, Matharu R, Singh PS. Colorimetric estimation of captopril and its formulations. Indian Drugs 1991;28:189–91.
8. Chandru H, Sharada AC. Simple and rapid methods for the analysis of captopril in dosage forms. E J Chem 2007;4:216–21.
9. Gumieniczek A, Kowalczuk D, Przyborowski L. The chromato-graphic and colorimetric methods for determination of captopril in tablets. Acta Pol Pharm 1998;55:21–4.
10. Bald E, Sypniewski S. Determination of thiol drugs in pharmaceutical formulations as their 5-pyridinium derivatives by high-performance liquid chromatography with ultraviolet detection. Fresenius J Anal Chem 1997;358:554–5.
11. Cavrini V, Gatti R, Dipreta AM, Raggi MA. Determination of thiol drugs in pharmaceutical formulations using ethacrynic-acid as a precolumn ultraviolet derivatizaon reagent. Chromatographia 1987;23:680–3.
12. Cavrini V, Gatti R, Andrisano V, Gatti R. 1,1’-[ethenylidenebis (sulfonyl)] bis-benzene: a useful pre-cromato¬graphic derivatization reagent for HPLC analyses of thiol drugs. Chromatographia 1996;42:515–20.
13. Favaro G, Fiorani M. Determination of pharmaceutical thiols by chromatography with electrochemical detection: use of an electrode with conductive carbon cement matrix, chemically modified with cobalt phthalocyanine. Anal Chim Acta 1996;332:249–55.
14. Bald E, Sypniewski S, Drzewoski J, Stepien M. Application of 2-halopyrinidium salts as ultraviolet derivatization reagents and solid-phase extraction for determination of captopril in human plasma by high performance liquid chromatography. J Chromatogr B: Biomed Appl 1996;681:283.
15. Jebaslinhepzybai B, Velmurugan C, Chenthilnathan A. Validation of the RP-HPLC method for analysis of captopril in pharmaceutical tablets. Der Pharm Sin 2016;7:1–6.
16. Leanpolchareanchai J, Suksiriworapong J. Validation of analytical method for captopril extemporaneous preparations by high performance liquid chromatography. MU J Pharm Sci 2015;42:85–92.
17. Sultan N, Naveed S, Arayne MS. RP-HPLC method for the simultaneous determination of captopril and H2-receptor antagonist: application to interaction studies. Med Chem 2013;3:183–7.
18. Huang T. Simultaneous determination of captopril and hydrochlorothiazide in human plasma by reverse-phase HPLC from linear gradient elution. J Pharma Biomed Anal 2006;41:644–8.
19. Sultana N, Arayne MS, Naveed S. Simultaneous quantitation of captopril and NSAID’s in API, dosage formulations and human serum by RP-HPLC. J Chin Chem Soc 2010;57:62–7.
20. Aykin N, Neal R, Yusof M, Ercal N. Determination of captopril in biological samples by high-performance liquid chromatography with ThioGlo™3 derivatization. Biomed Chromatogr 2001;15:427–32.
21. Gao S, Weirong T, Shixiang W. Simple highperformance liquid chromatographic method for the determination of captopril in biological fluids. J Chromatogr B: Biomed Appl 1992;582:258–62.
22. Li K, Tan L, Zhou J. HPLC determination of captopril in human plasma and its pharmacokinetic study. Biomed Chromatogr 1996;10:237–9.
23. Ito T, Matsuki Y, Kurihara H, Nambara T. Sensitive method for determination of captopril in biological fluids by gas chromatography-mass spectrometry. J Chromatogr 1987; 417:79–87.
24. Y Matsuki. Determination of captopril in biological fluids by gas-liquid chromatography. J Chromatogr 1993;188:177–83.
25. Papanov S, Hadjieva B, Koleva N. Rapid RP-HPLC method for estimation of captopril from tablet dosage form. Int J Biol Pharm Allied Sci 2014;3:317–25.
26. Yuliya Kondratova, Liliya Logoyda, Yuliia Voloshko, Ahmed Abdel Megied, Dmytro Korobko, Yuriy Soroka. Development and validation of HPLC-DAD method for the determination of bisoprolol in tablet dosage forms. Int J Appl Pharma 2017;9:54-9.
27. Kondratova Y, Adebayo T, Logoyda L, Korobko D, Berdey I, Kuchmerovska T. Development of the methodology of the chromatographic determination of amlodipine in medicines. Int J Res Ayurveda Pharm 2016;7:32-5.
28. Liliya Logoyda, Yuliya Kondratova, Dmytro Korobko, Yuriy Soroka. Development of UHPLC method for the determination of captopril in pharmaceutical dosage forms. Asian J Pharm Clin Res 2017;10:308-10.
29. Liliya Logoyda, Ahmed M Abdel-Megied, Yuliya Kondratova, Olena Trofimenko, Dmytro Korobko, Iryna Dakhym. Development and validation of HPLC method for the simultaneous determination of enalapril maleate in present of their impurities: application to tablet analysis. Int J Appl Pharm 2018;10:98-102.
30. Liliya L, Dmytro K, Olena S, Ihor B, Tamara K. Development of methodology for identification of captopril in medicines. Asian J Pharm 2016;10:168-71.
31. Logoyda L, Korobko D, Saprun S, Zarivna N. Development of methods for the chromatographic identification of active pharmaceutical ingredient from group of angiotensin-converting enzyme inhibitors in pharmaceuticals. Int J Green Pharm 2017;11 Suppl:737–41.
32. Liliya Logoyda, Dmytro Korobko, Iryna Ivanusa, Kovalenko Serhii. Development of the methodology of the chromatographic determination of nifedipine in medicines. Asian J Pharm Clin Res 2017;10:149-52.
33. Logoyda Liliya, Korobko Dmutro, Saprun Stanislav. Development of methods for identification of calcium channel blockers in medicines. Int J Res Ayurveda Pharm 2016;7:88-91.
34. Olgya Polyauk, Liliya Logoyda. The investigation of conditions of API from group of calcium channel blockers extraction by organic solvents by using high-performance liquid chromatography as method assay. Asian J Pharm Clin Res 2017;10:354-6.
35. Kondratova Y, Adebayo T, Logoyda L, Korobko D, Berdey I, Kuchmerovska T. Development of the methodology of the chromatographic determination of amlodipine in medicines. Int J Res Ayurveda Pharm 2016;7:32-5.
36. Logoyda L, Abdel Megied AM, Kondratova Y, Trofimenko O, Korobko D, Dakhym I. Development and validation of HPLC method for the simultaneous determination of enalapril maleate in present of their impurities: application to tablet analysis. Int J Appl Pharm 2018;10:98-102.
37. Liliya Logoyda, Dmytro Korobko, Oleksandra Oleshchuk, Taras Proniv, Mariya Dmutriv. A HPLC MS/MS method development and validation for the simultaneous determination of bisoprolol and enalapril in the present of enalaprilat in human plasma. Int J Appl Pharm 2018;10:31-40.
38. Logoyda L, Mykhalkiv M, Polyauk O, Zarivna N, Soroka Y, Demydiak O. Ultra-high-performance liquid chromatography as assay method for the investigation of conditions of captopril extraction by organic solvents. Asian J Pharm 2018;12 Suppl:111-4.
39. Mykhalkiv M, Logoyda L, Polyauk O, Zarivna N, Soroka Y, Ryabokon S, Riabokon M. HPLC as assay method for the investigation of conditions of bisoprolol extraction by organic solvents. Int J Green Pharm 2018;12 Suppl:276–9.
40. Liliya Logoyda. Bioanalytical method development and validation from the simultaneous determination of verapamil and enalapril in the present of enalaprilat by HPLC MS/MS. Int J Appl Pharm 2018;10:19-27.
41. Liliya Logoyda. Quantitative determination of amlodipine from caco-2 cell monolayers by high-performance liquid chromatography-mass spectrometry/mass spectrometry. Asian J Pharm Clin Res 2018;11:204-7.
42. Yuryeva O, Kondratova Y, Logoyda L. Development of high-performance liquid chromatography method for simultaneous analysis of amlodipine and valsartan in combined dosage form and in vitro disslotution studies. Asian J Pharm Clin Res 2018;11:200-4.
43. Mykhalkiv M, Logoyda L, Ivanusa I, Soroka Y, Yakubishyna I. High-performance liquid chromatography as assay method for the investigation of conditions of enalapril maleate extraction by organic solvents. Int J Green Pharm 2018;12:62-5.
44. Logoyda L, Kondratova Y, Korobko D, Susla O, Soroka Y, Tsytsiura R, Pidruchna S. Youden's test of the chromatographic determination of captopril in pharmaceuticals. Int J Green Pharm 2017;11:188-91.
45. Liliya Logoyda. A HPLC-MS/MS method development and validation for the simultaneous determination of nifedipine and enalapril in human plasma. Int J Appl Pharm 2018;10:35-42.
46. Liliya Logoyda. A high-performance liquid chromatography-mass spectrometry method development for the quantitative determination of enalapril maleate from caco-2 cell monolayers. Asian J Pharm Clin Res 2018;11:89-92.
47. Logoyda L, Korobko D. A high-performance liquid chromatography-mass spectrometry/mass spectrometry method development for the quantitative determination of bisoprolol from caco-2 cell monolayers. Asian J Pharm Clin Res 2018;11:386–9.
48. SK Dubey, S Kumar, RJ Mudakavi, S Deshpande. Development and validation of UV-spectrophotometric method for determination of Enalapril maleate. Int J Adv Pharm Sci 2010;1:375–80.
49. Ayad MM, Shalaby AA, Abdeellatef HE, Hosny MM. Spectrophotometric and AAS determination of ramipril and enalapril through ternary complex formation. J Pharm Biomed Anal 2002;28:311-21.
50. Baraka MM, El Sadek M, Mousa EM, Abd Alaty NM. Spectrophotometric and atomic absorption determination of ramipril, enalapril maleate and fosinopril through ternary complex formation with molybdenum (V)–thiocyanate (Mo (V)–SCN). Chem Pharm 2008;56:1521–7.
51. Ayad MM, Shalaby A, Abdellatef HE, Hosny MM. Spectrophotometric methods for determination of enalapril and timolol in bulk and in drug formulations. J Pharm Biomed Anal 2002;28:311-21.
52. Stolarczyk M, Maslanka A, Krzek J, Milczarek J. Application of derivative spectrophotometry for determination of enalapril, hydrochlorothiazide and walsartan in complex pharmaceutical preparations. Acta Poloniae Pharm 2008;65:275-81.
53. Sowjanya G. Simultaneous UV spectrophotometric estimation of enalapril maleate and hydrochlorothiazide in tablets. J Chem Pharm Res 2012;4:3483–8.
54. Patil PS, More HN. Difference spectrophotometric estimation of enalapril maleate from tablet dosage form. Int J Res Pharm Biomed Sci 2011;2:629-33.
55. Rahman N, Manirul Haque SK. Optimized and validated spectrophotometric methods for the determination of enalapril maleate in commercial dosage forms. Anal Chem Insights 2008;3:31–43.
56. Gherman S, Zavastin D, Spac A, Dorneanu V. Development and validation of UV spectrophotometric method for determination of enalapril maleate from commercial dosage forms. Farmacia 2015;63:934–7.
57. Manindra M, Zafar HS, Ankur K. Validation of stability indicating HPLC method for the determination of enalapril maleate in tablet formulations. Int J Pharm Pharm Sci 2011;3 Suppl 5:180–3.
58. Al-Momani F. Determination of hydrochlorothiazide and enalapril maleate in tablet formulations by reversed-phase. Turk J Chem 2001;25;49–54.
59. Vidyadhara BV Rao, K Tejaswiand, AL Rani. Analytical method development and validation for simultaneous estimation of enalapril maleate and hydrochlorothiazide by RP-HPLC/S. Der Pharm Chem 2014;6:217–23.
60. Chaudhari BG. Development and validation of Rp-Hplc method for simultaneous stimation of enalapril maleate and amlodipine besylate in combined dosage form. J Appl Pharm Sci 2012;2:54–7.
61. Sultana N, Saeed A, Naveed S. Simultaneous determination of enalapril and statin's in pharmaceutical formulations by Rp-hplc. J Chilean Chem Soc 2011;56:734–7.
62. Chaitanya Sai B, Satish Kumar V, Satish Babu K, Ravindra Babu SVD. Simultaneous high-performance liquid chromatographic determination of enalapril and felodipine in pharmaceutical-dosage form. J Chem Pharm Res 2012;4:1383–8.
63. Nagarajan G. Development and validation of a RP-HPLC method for simultaneous estimation of enalapril maleate and ramipril in bulk and tablet dosage form. Der Pharm Lett 2013;5:69–76.
64. Walily AM, Belal SF, Heaba EA, Kersh AE. Simultaneous determination of enalapril maleate and hydrochlo¬ro¬thiazide by first-derivative ultraviolet spectrophotometry and high-performance liquid chromatography. J Pharm Biomed Anal 1995;13:851–56.
65. Tajerzadeh H, Hamidi M. A simple HPLC method for quantitation of enalaprilat. J Pharm Biomed Anal 2001;24:675–880.
66. Uslu B, Ozden T. HPLC and UPLC methods for the simultaneous determination of enalapril and hydrochlorothiazide in pharmaceutical dosage forms. Chromatographia 2013;76:1487–94.
67. Danafar H, Hamidi M. Liquid chromatography–tandem mass spectrometry (LC-MS) method for the assignment of enalapril and enalaprilat in human plasma. Pharm Biomed Res 2015;1:47–58.
68. Yoon KH, Kim W, Park J, Kim HJ. Quantification of enalapril in human plasma by liquid chromatography–tandem mass spectrometry. Bull Korean Chem Soc 2004;25:878–80.
69. Shioya H, Shimojo M, Kawahara Y. Determination of enalapril and its active metabolite enalaprilat in plasma and urine by gas chromatography/mass spectrometry. Biomed Chromatogr 1992;6:59–62.
70. Lee J. Simultaneous quantitation of enalapril and enalaprilat in human plasma by 96-well solid-phase extraction and liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom 2003;17:1157–62.
71. Kocijan A, Grahek R, Kocjan D, Kralj LZ. Simultaneous quantitation of enalapril and enalaprilat in human plasma by 96-well solid-phase extraction and liquid chromatography/tandem mass spectrometry. J Chromatogr B 2001;755:229–39.
72. Qi Gu, Dafang Zhong, Xiaoyan Chen, Yingwu Wang. Simultaneous quantitation of enalapril and enalaprilat in human plasma by liquid chromatography/tandem mass spectrometry. J Chromatography B 2005;813:337–42.
73. Bhardwaj SP, Singh S. Study of forced degradation behavior of enalapril maleate by LC and LC–MS and development of a validated stability-indicating assay method. J Pharma Biomed Anal 2008;46:113–20.
74. Niopas I, Daftsios AC, Nikolaidis N. Bioequivalence study of two brands of enalapril tablets after single oral administration to healthy volunteers. Int J Clin Pharmacol Ther 2003;41:226–30.
75. Siddiqui FA, Sher N, Shafi N, Bahadur SS. Simultaneous determination of metformin, captopril, lisinopril, and enalapril, its application to pharmacokinetics. Arabian J Chem 2013;5:324.
This work is licensed under a Creative Commons Attribution 4.0 International License.