ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF SOME ACTIVE PHARMACEUTICAL INGREDIENTS FROM THE GROUP OF CALCIUM CHANNEL BLOCKERS IN DRUGS AND BIOLOGICAL LIQUIDS

  • Liliya Logoyda Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil State Medical University, Ukraine

Abstract

Calcium channel blockers prevent calcium from entering cells of the heart and blood vessel walls, resulting in lower blood pressure. Calcium channel blockers, also called calcium antagonists, relax and widen blood vessels by affecting the muscle cells in the arterial walls. Physico-chemical analysis methods are increasingly being introduced into fundamental pharmaceutical research and pharmaceutical analysis practice, taking into account their high sensitivity, accuracy, specificity and expressiveness.
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 calcium channel blockers. 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 of calcium channel blockers. The sources were  world recognized journals and key words used as filter were calcium channel blockers, amlodipine, nifedipine, verapamil, validation, method development, spectrophotometry, HPLC,  UHPLC. Chromatographic methods of analysis amongst others have the greatest specificity and objectivity and allow for qualitative and quantitative determination of API in combinated dosage forms and biological fluids without prior separation of the components. We can conclude that analysts are constantly working on developing new methods of analysis and their optimization in order to save time and consumables, which also ensures the efficiency of the developed method. The main disadvantage of the described methods of API analysis can be considered long term from the beginning of chromatography to API release and specific solvents used as the mobile phase in HPLC. It is necessary to develop methods and to select such chromatographic conditions that will provide high speed and high efficiency at lower pressure of the system. This reduces the amount of used mobile phase, which reduces cost analysis accordingly, while at the same time providing the necessary specificity, accuracy and reproducibility of the results of the analysis during quality control. Also, the reduction of analysis time is achieved by simplifying the conditions for sample preparation.

Keywords: Calcium channel blockers, Amlodipine, Nifedipine, Verapamil, Validation

References

1. https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/calcium-channel-blockers/art-20047605. [Last accessed on 10 Jan 2019]
2. https://en.wikipedia.org/wiki/Calcium_channel_blocker. [Last accessed on 10 Jan 2019]
3. https://pubchem.ncbi.nlm.nih.gov. [Last accessed on 10 Jan 2019].
4. Altiokka G, Altiokka M. Flow injection analysis of amlodipine using UV-detection. Pharmazie 2002;57:500–3.
5. Gohil K, Trivedi P, Molvi KI. Spectrophotometric analysis of amlodipine besylate in bulk and in tablet dosage forms. Indian J Pharma Sci 2005;67:376–8.
6. Chaudhari BG, Patel AB. Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine besylate in tablet dosage forms. Int J Chem Tech Res 2010;2:633–9.
7. Dake AS, Kasture VS, Ryed M. A kinetic spectrophotometric method for determination of amlodipine and nifedipine in pharmaceutical preparations. Indian Drugs 2002;39:14–7.
8. Jain HK, Agrawal RK. Spectrophotometric method for simultaneous estimation of amlodipine besylate and lisinopril in tablet. Indian Drugs 2000;37:196–9.
9. Sahu R, Patel Vandana B. Simultaneous spectrophotometric determination of amlodipine besylate and atorvastatin calcium in binary mixture. Indian J Pharma Sci 2007;69:110–1.
10. Khan MR, Jain Deepti. Simultaneous spectrophotometric determination of atorvastatin calcium and amlodipine besylate in tablets. Indian J Pharma Sci 2006;68:546–8.
11. Meyya SN, Nathan GV, Suresh B. Simultaneous spectrophotometric estimation of benazepril and amlodipine besylate in their dosage form. Indian Pharmacist 2003;2:100–1.
12. Prasad CVN, Saha RN, Parimoo P. Simultaneous determination of amlodipine-enalapril maleate and amlodipine-lisinopril in combined tablet preparations by derivative spectro-photometry. Pharm Pharmacol Comm 1999;5:383–8.
13. Ragno G, Garofalo A, Vetuschi C. Photodegradation monitering of amlodipine by derivative spectrophotometry. J Pharm Biomed Anal 2002;27:19–24.
14. Ayad MM, Abdellatef HE, Hosny MM, Sharaf YA. Spectrophotometric and spectrofluorimetric determination of amlodipine besilate and doxazosin mesilate in bulk and in dosage forms. Int J Pharm Biomed Res 2012;3:111–6.
15. Basavaiah K, Chandrashekar U, Nagegowda P. Spectro-photometric and high performance liquid chromatographic determination of amlodipine besylate in pharmaceuticals. Sci Asia 2005;31:13–21.
16. Wankhede SB, Raka KC, Wadkar SB, Chitlange SS. Spectrophotometric and HPLC methods for simultaneous estimation of amlodipine besilate, losartan potassium and hydrochlorothiazide in tablets. Indian J Pharm Sci 2010;72:136–40.
17. Bhushan R, Gupta D, Singh SK. Liquid chromatographic separation and UV determination of certain antihypertensive agents. Biomed Chromatogr 2006;20:217–24.
18. Alizadeh N, Hemati F. Spectrophotometric method for the determination of amlodipine besylate in pure and dosage forms using 7,7,8,8–tetracyanoquino¬dimethane and tetracyano-ethylene. Bull Faculty Pharm Cairo University 2014;52:109–14.
19. Hemmateenejad B, Miri R, Kamali R. A kinetic spectrophotometric method for determination of amlodipine and nifedipine in pharmaceutical preparations. J Iran Chem Soc 2009;1:113–20.
20. Mahmoud AM, Abdel Wadood HM, Mohamed NA. Kinetic spectrophotometric method for determination of amlodipine besylate in its pharmaceutical tablets. J Pharm Anal 2012;2:334–41.
21. Mohammadi A. A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. J Chromatogr B 2007;846:215–21.
22. Aravindraju S, Muralidharan S, Meyyanathan SN, Suresh B. A validated RP-HPLC method for simultaneous estimation of losartan potassium and amlodipine in pharmaceutical formulation. Anal Chem (Rajkot, India) 2006;3:66–70.
23. Sivakumar T, Manavalan R, Muralidharan C, Valliappan K. An improved HPLC method with the aid of a chemometric protocol: simultaneous analysis of amlodipine and atorvastatin in pharmaceutical formulations. J Sep Sci 2007;30:3143–53.
24. Kumar DB. 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.
25. Argekar AP, Powar SG. Simultaneous determination of atenolol and amlodipine in tablets by high-performance thin-layer chromatography. J Pharm Biomed Anal 2000;21:1137–42.
26. Aryal S, Skalko Basnet N. Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types. Acta Pharm 2008;58:299–308.
27. Avadhanulu AB, Srinivas JS, Anjaneyulu Y. Reverse phase HPLC determination of amlodipine besylate in drug and its pharmaceutical dosage forms. Indian Drugs 1996;33:36–40.
28. Bharat G Chaudhari. 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.
29. Bhushan R, Tanwar S. Reversed-phase high-performance liquid chromatographic enantioresolution of six ?-blockers using dinitrophenyl-l-Pro-N-hydroxysuccinimide ester, N-succinimidyl-(S)-2-(6-methoxynaphth-2-yl) propionate and twelve variants of sanger's reagent as chiral derivatizing reagents. Biomed Chromatography 2009;23:1291–9.
30. Chitlange S, Imran M, Sakarkar D. RP-HPLC method for simultaneous estimation of amlodipine and metoprolol in tablet formulation. Asian J Pharm 2008;2:232.
31. Chitlange SS, Bagri K, Sakarkar DM. Stability indicating RP-HPLC method for simultaneous estimation of valsartan and amlodipine in capsule formulation. Asian J Res Chem 2008;7:15–8.
32. Pandya KK, Satia M, Gandhi TP, Modi IA. Detection and determination of total amlodipine by high-performance thin-layer chromatography: a useful technique for pharmacokinetic studies. J Chromatogr B 1995;667:315–20.
33. Malesuik MD. Determination of amlodipine in pharmaceutical dosage forms by liquid chromatography and ultraviolet spectrophotometry. J Pharm Biomed Anal 2005;89:359–64.
34. Altiokka G, Dogrukol-Ak D, Tuncel M, Aboul Enein HY. Determination of amlodipine in pharmaceutical formulations by differential-pulse voltammetry with a glassy carbon electrode. Archiv Der Pharmazie (Weinheim) 2002;335:104–8.
35. Dai SY, Qiu ST, Wu W, Fu CM. Development and validation an RP–HPLC method for simultaneous determination of ramipril and amlodipine in tablets. J Pharma Anal 2013;3:440–6.
36. Prathyusha W. Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of aliskerin hemifumarate, amlodipine besylate and hydrochlorothiazide in bulk and pharmaceutical dosage forms. J Pharm Bio Sci 2014;9:114–23.
37. Momin MAM, Islam MM, Rahman KH, Sh Md Anisuzzaman. Development and validation of assay method of amlodipine tablet by HPLC. Int J Pharm Phytopharmacol Res 2012;2:109–15.
38. Pathak SU, Saple SR, Vaidya VV, Kekare MB. Development and validation of RP-HPLC methods for simultaneous estimation of amlodipine, hydrochlorothiazide and olm?sartan medoxomil in tablets formulation. Anal Chem Indian J 2011;10:624–7.
39. Moon HW. Evaluation of stability and simultaneous determination of fimasartan and amlodipine by a HPLC method in combination tablets. Asian J Pharma Sci 2014;9:123–8.
40. Gawri N, Vaidhyalingam V, Santha A. HPTLC method for the simultaneous estimation of amlodipine besylate and benazepril HCl tablets. Indian Drugs 2003;40:645–8.
41. Gowri N, Vaidhyalingam V, Santha A. Simultaneous estimation of amlodipine and benazepril from tablet by RP-HPLC. Indian Drugs 2002;39:532–5.
42. Halkar UP, Bhandari NP, Rane SH. High performance liquid chromatographic simultaneous determination of amlodipine and enalapril maleate from pharmaceutical preparations. Indian Drugs 1998;35:168–9.
43. Kul D. High-performance liquid chromatographic and first derivative of the ratio spectrophotometric determination of amlodipine and valsartan in their binary mixtures. J AOAC Int 2010;93:882–90.
44. Kulkarni AP, Gat GV, Pimple SV, Joshi MA. HPLC method for determination of losartan potassium and amlodipine besylate in tablets. Indian Drugs 2003;40:298–9.
45. Ilango K, Kumar PB, Lakshmi KS. Simple and rapid HPTLC estimation of amlodipine and atenolol from pharmaceutical dosages. Indian Drugs 2000;37:497–9.
46. Kamble N, Venkatachalam A. Determination and validation of HPLC method for simultaneous determination of lisinopril and amlodipine from tablet. Indian Drugs 2004;41:179–81.
47. Kavathia A, Misra M. Development and validation of RP–HPLC and UV–spectrophotometric methods for rapid simultaneous estimation of amlodipine andbenazepril in pure and fixed dose combination. Arabian J Chem 2013;10 Suppl 2:S3021-S3028.
48. Kazemipour M. Use of adsorptive square-wave anodic stripping voltammetry at carbon paste electrode for the determination of amlodipine besylate in the pharmaceutical preparations. ???? ?????? ????? 2009;64:74–9.
49. Li C, Yan X, Shan W. HPLC determination of amlodipine besylate tablets. Yaowu Fenxi Zazhi 2006;26:1878–9.
50. Shalini P, Krishan P. Development and validation of a simultaneous HPLC method for assay and dissolution of bisoprolol fumarate and amlodipine besylate in pharmaceutical dosage. Res J Pharm Dosage Forms Technol 2012;4:62–6.
51. Kayal SD. 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.
52. Meyyanathan SN, Suresh B. HPTLC method for the simultaneous determination of amlodipine and benazepril in their formulations. J Chromatogr Sci 2005;43:73–5.
53. Naidu KK, Kale UN, Shingare MS. Stability indicating RPHPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product. J Pharm Biomed Anal 2005;39:147–55.
54. Patki RV, Tamhankar CP, Tipnis HP. Simple and rapid high performance liquid chromatographic estimation of amlodipine from pharmaceutical dosage. Indian Drugs 1994;31:560–1.
55. Rajkondawar VV. Simultaneous determination of atorvastatin and amlodipine by reverse phase high performance liquid chromatography. Asian J Chem 2006;18:3227–9.
56. Raju VB, Rao AL. Simultaneous estimation of perindopril and amlodipine in combined dosage form by RP-HPLC method. Int J Chem Sci 2011;9:1290–7.
57. Shah DA. RP-HPLC determination of atorvastatin calcium and amlodipine besylate combination in tablets. Indian J Pharm Sci 2006;68:796–9.
58. Rajeswari KR. RP-HPLC method for the simultaneous determination of atorvastatin and amlodipine in tablet dosage form. Indian J Pharm Sci 2006;68:275–7.
59. Rao MMP, Rahaman SA, Prasad YR, Reddy PG. RP–HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. Int J Pharma Res Dev 2010;2:69–76.
60. Luksa J. Semi-preparative chromatographic purification of the enantiomers S-(-)-amlodipine and R-(+)-amlodipine. J Chromatogr B 1997;693:367–75.
61. Shang F, Shang K. Determination of amlodipine in tablets by HPLC. Zhongguo Yiyao Gongye Zazhi 1996;27:411–3.
62. Shah DA. Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations. Indian J Pharm Sci 2008;70:754–60.
63. Xiao H, Wang Y. Study on preparation and quality standard of amlodipine besylate tablets. Zhongguo Yaoye 2007;16:30–2.
64. Yeole MP, Asnani AJ. Simultaneous determination of telmisartan and amlodipine in tablets by reverse phase high performance liquid chromatography. Res J Pharm Technol 2011;4:75–7.
65. Bhatt J. A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the estimation of amlodipine in human plasma. J Biomed Chromatogr Sci Appl 2007;21:169–75.
66. Alsarra IA. High-performance liquid chromatographic method for quantitative determination of amlodipine in human plasma and pharmaceutical dosage form and its application to pharmacokinetic studies. J Chromatogr Sci 2009;47:863–7.
67. Feng Y. Analysis of amlodipine in human plasma by liquid chromatography-mass spectrometry. J Chromatogr Sci Appl 2002;40:49–53.
68. Zarghi A, Foroutan SM, Shafaati A, Khoddam A. Validated HPLC method for determination of amlodipine in human plasma and its application to pharmacokinetic studies. Farmaco 2005;60:789–92.
69. Bahrami G, Mirzaeei S. Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies. J Pharm Biomed Anal 2004;36:163–8.
70. Streel B. Enantiomeric determination of amlodipine in human plasma by liquid chromatography coupledto tandem mass spectrometry. J Biochem Biophys Methods 2002;54:357–68.
71. Ma Y. Determination and pharmacokinetic study of amlodipine in human plasma by ultra performance liquid chromatography-electrospray ionization mass spectrometry. J Pharm Biomed Anal 2007;43:1540–5.
72. Freddy H, Chaudhari V. Simultaneous determination of atorvastatin calcium and amlodipine besylate from pharmaceutical formulation by reversed phase high performance liquid chromatography. Asian J Chem 2005;7:2502–8.
73. Yu Q. HPLC-MS-MS for the simultaneous determination of atorvastatin and amlodipine in plasma of hypertensive patients. Chromatographia 2011;73:257–62.
74. Wei X, Yang G, Qi L, Chen Y. Determination of nicardipine and amlodipine in human plasma using on-line solid-phase extraction with a monolithic weak cation-exchange column. Talanta 2009;77:1197–202.
75. Ramani AV, Sengupta P, Mullangi R. Development and validation of a highly sensitive and robust LC-ESI-MS/MS method for simultaneous quantitation of simvastatin acid, amlodipine and valsartan in human plasma: application to a clinical pharmacokinetic study. Biomed Chromatogr 2009;23:615–22.
76. 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 Pharm 2017;9:54-9.
77. 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.
78. 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.
79. 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.
80. 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.
81. 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.
82. 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.
83. 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.
84. 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.
85. 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.
86. 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.
87. 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.
88. 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 Pharma 2018;12 Suppl:111-4.
89. Mykhalkiv M, Logoyda L, Polyauk O, Zarivna N, Soroka Y, Ryabokon S, et al. HPLC as assay method for the investigation of conditions of bisoprolol extraction by organic solvents. Int J Green Pharm 2018;12 Suppl:276–9.
90. 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.
91. 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.
92. 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.
93. 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;12:62-65.
94. Logoyda L, Kondratova Y, Korobko D, Susla O, Soroka Y, Tsytsiura R, et al. Youden's test of the chromatographic determination of captopril in pharmaceuticals. Int J Green Pharm 2017;11:188-91.
95. 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.
96. 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.
97. 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.
98. Dinakaran SK. Spectrophotometric method development and validation for atorvastatin calcium and nifedipine HCl in bulk and tablet dosage form using absorption ratio method assay of atorvastatin and nifedipine. J Pharm Res 2013;7:666–9.
99. Revathi R. New spectroscopic determination of nifedipine using hydrotropic solubilization. Int J Pharm Pharm Sci 2010;2:74–6.
100. Hamidi N, Taib MN, Wui WT. Analysis of nifedipine content in transdermal drug delivery system using non-destructive visible spectrophotometry technique. Malaysian J Anal Sci 2008;12:348–51.
101. Tulasamma P, Venkateswarlu P. Spectrophotometric determination of nifedipine in pharmaceutical formulations, serum and urine samples via oxidative coupling reaction. Arabian J Chem 2016;9(Suppl 2):S1603–S1609.
102. Modi Dixita V, Patel Paresh U. Development and validation of simultaneous equation method for simultaneous estimation of telmisartan and nifedipine in synthetic mixture. Int Res J Pharm 2016;7:6–9.
103. Al-Ghannam SM, AlOlyan AM. Spectrofluorometric determination of nicardipine, nifedipine and isradipine in pharmaceutical preparations and biological fluids. Centr Eur J Chem 2008;6:222–8.
104. Bing L, Hu DF, Liu F. HPLC determination of atenolol and nifedipine in compound atenolol tablets. Yaowu Fenxi Zazhi 2004;24:485–6.
105. Galan Rodriguez C, González Alvarez J, Valls Remolí M. Method development and validation study for quantitative determination of nifedipine and related substances by ultra-high-performance liquid chromatography. Biomed Chromatogr 2015;29:233–9.
106. DM Milenovic, ML Lazic, VB Veljkovic, ZB Todorovic. Validation of an HPLC method for analysis of nifedipine residues on stainless–steel surfaces in the manufacture of pharmaceuticals. Acta Chromatographica 2008;20:183–94.
107. Rosseel MT, Bogaert MG. Determination of nifedipine in human plasma by capillary gas chromatography with nitrogen detection. J Chromatogr 1983;279:675–80.
108. Soons PA, Schellens JH, Roosemalen MC, Breimer DD. Analysis of nifedipine and its pyridine metabolite dehydronifedipine in blood and plasma: review and improved high-performance liquid chromatographic methodology. J Pharm Biomed Anal 1991;9:475–84.
109. Guo Y. Determination of nifedipine in human plasma and its use in bioequivalence study. Int J Pharm 2007;341:91–6.
110. Wang D. Determination of nifedipine in human plasma by ultra performance liquid chromatography–tandem mass spectrometry and its application in a pharmacokinetic study. J Chromatography B 2011;879:1827–32.
111. Guellec C Le, Bun H, Giocanti M, Durand A. Determination of nifedipine in plasma by a rapid capillary gas chromatographic method. Biomed Chromatogr 1992;6:20–3.
112. Zendelovska D. Development of an HPLC method for the determination of nifedipine in human plasma by solid-phase extraction. J Chromatogr B: Anal Technol Biomed Life Sci 2006;839:85–8.
113. Patrick KS, Jarvi EJ, Straughn AB, Meyer MC. Gas chromatographic mass spectrometric analysis of plasma nifedipine. J Chromatogr 1989;495:123–30.
114. Gurley BJ, Buice RG, Sidhu P. Reversed-phase high performance liquid chromatographic determination of nifedipine in human plasma. Ther Drug Monit 1985;7:321–3.
115. Jankowski A, Lamparczyk H. Evaluation of chromatographic methods for the determination of nifedipine in human serum. J Chromatogr A 1994;668:469–73.
116. Abou-Auda HS. Liquid chromatographic assay of nifedipine in human plasma and its application to pharmacokinetic studies. J Pharm Biomed Anal 2000;22:241–9.
117. Mosab A, Zahaa A, Momir M. Determination of nifedipine in rat plasma using HPLC-UV detector: a simple method for pharmacokinetics and oral bioavailability studies. Int J Pharm Sci 2016;8:98–102.
118. Yritia M, Parra P, Iglesias E, Barbanoj JM. Quantitation of nifedipine in human plasma by on-line solid-phase extraction and high-performance liquid chromatography. J Chromatogr A 2000;870:115–9.
119. Wang XD. Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: application to a clinical herb-drug interaction study. J Chromatogr B: Anal Technol Biomed Life Sci 2007;852:534–44.
120. Schmid BJ, Perry HE, Idle JR. Determination of nifedipine and its three principal metabolites in plasma and urine by automated electron-capture capillary gas chromatography. J Chromatogr 1988;425:107–19.
121. Streel B, Zimmer C, Sibenaler R, Ceccato A. Simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B: Biomed Sci Appl 1998;720:119–28.
122. Salh DM. Spectrophotometric determination of isoptin (Verapamil Hydrochloride) in pharmaceutical preparations using bromothymol blue reagent. Int J Chem Environ Eng 2012;3:15–20.
123. Rahman N, Hoda MN. Spectrophotometric determination of verapamil hydrochloride in drug formations with chloramine-T as oxidant. Anal Bioanal Chem 2002;374:484-9.
124. Rahman N, Hejaz Azmi SN. Spectrophotometric method for the determination of verapamil hydrochloride in pharmaceutical formulations using N-bromosuccinimide as oxidant. Farmaco 2004;59:529–36.
125. Rahman N, Khan NA, Hejaz Azmi SN. Optimized and validated spectrophotometric methods for the determination of verapamil hydrochloride in drug formulations. Sci Asia 2005;31:341–8.
126. Hasanzadeh M, Pournaghi Azar MH, Shadjou N, Jouyban A. A verapamil electrochemical sensor based on magnetic mobile crystalline material–41 grafted by sulfonic acid. Electrochimica Acta 2013;89:660–8.
127. Chen A, Tsao MJ, Chuang JF, Lin Ch H. Electrochemical determination of verapamil with a microchip embedded with gold nanoelectrode ensemble electrodes. Electrochimica Acta 2013;89:700–7.
128. Li-Jun LI. Electrochemiluminescence of sodium dodecyl sulfate-ru(bpy)3 2+–verapamil hydrochloride system and its application. Chin J Anal Chem 2011;39:1033–7.
129. Semaan FS, Cavalheiro ETG, Brett Ch MA. Electrochemical behavior of verapamil at graphite–polyurethane composite electrodes: determination of release profiles in pharmaceutical samples. Anal Lett 2009;42:1119–35.
130. Srinivasan V, Sivaramakrishnan H, Karthikeyan B. Detection, isolation and characterization of principal synthetic route indicative impurities in verapamil hydrochloride. Sci Pharm 2011;79:555–68.
131. Ivanova V, Zendelovska D, Stefova M, Stafilov T. HPLC method for determination of verapamil in human plasma after solid–phase extraction. J Biochem Biophys Methods 2008;70:1297–303.
132. Unadkat JD. Rapid solid–phase extraction method to quantify 11C–verapamil, and its 11C–metabolites, in human and macaque plasma. Nucl Med Biol 2008;35:911–7.
133. Mallik R, Yoo MJ, Chen S, Hage DS. Studies of verapamil binding to human serum albumin by high–performance affinity chromatography. J Chromatogr B: Biomed Sci Appl 2008;876:69–75.
134. Sawicki W. A validated method for the determination of verapamil and norverapamil in human plasma. J Pharm Biomed Anal 2001;25:689–95.
135. Hubert PH. Determination of verapamil and norverapamil in human plasma by liquid chromatography: comparison between a liquid–liquid extraction procedure and an automated liquid–solid extraction method for sample preparation. J Pharm Biomed Anal 1992;10:937–42.
136. Stagni G, Gillespie WR. Simultaneous analysis of verapamil and norverapamil enantiomers in human plasma by high-performance liquid chromatography. J Chromatogr B 1995;667:349–54.
137. Jhee OH. Direct determination of verapamil in rat plasma by coupled column microbore HPLC method. J Pharm Biomed Anal 2005;37:405–10.
138. Negrusz A, Wacek BC, Toerne T, Bryant J. Quantitation of verapamil and norverapamil in postmortem and clinical samples using liquid–liquid extraction, solid phase extraction, and HPLC. Chromatographia 1997;46:191–6.
139. Muscara MN, de-Nucci G. Measurement of plasma verapamil levels by high-performance liquid chromatography. Braz J Med Biol Res 1993;26:753–63.
140. Lau Cam CA, Piemontese D. Simplified reversed-phase HPLC method with spectrophotometic detection for the assay of verapamil in rat plasma. J Pharm Biomed Anal 1998;16:1029–35.
141. M Hedeland, E Fredriksson, H Lennernäs, U Bondesson. Simultaneous quantification of the enantiomers of verapamil and its N-demethylated metabolite in human plasma using liquid chromatography-tandem mass spectrometry. J Chromatogr B: Anal Technol Biomed Life Sci 2004;804:303–11.
142. Von Richter O, Eichelbaum M, Schonberger F, Hofmann U. Rapid and highly sensitive method for the determination of verapamil, [2H7] verapamil and metabolites in biological fluids by liquid chromatography–mass spectrometry. J Chromatogr B: Biomed Sci Appl 2000;738:137–47.
143. Krynytska I, Marushchak M, Zaets T, Savchenko I, Habor H. Investigation of bone mineralization in patients with coronary heart disease complicated by chronic heart failure, stage II-A. Georgian Med News 2017;267:43-8.
144. Marushchak M, Krynytska I, Mikolenko A, Andreychyn Y, Bodnar Y, Chornomydz I. Chronic heart failure causes osteopathy or is osteopathy a factor in development of chronic heart failure. Asian J Pharm Clin Res 2018;11:111-5.
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Logoyda, L. (2019). ANALYSIS OF APPROACHES TO THE DEVELOPMENT AND VALIDATION OF THE METHODS OF ANALYSIS OF SOME ACTIVE PHARMACEUTICAL INGREDIENTS FROM THE GROUP OF CALCIUM CHANNEL BLOCKERS IN DRUGS AND BIOLOGICAL LIQUIDS. International Journal of Applied Pharmaceutics, 11(3), 26-34. https://doi.org/10.22159/ijap.2019v11i3.32498
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Review Article(s)