HPLC METHOD DEVELOPMENT FOR THE ANALYSIS OF BISOPROLOL IN COMBINED DOSAGE FORM CONTAINING BISOPROLOL AND ENALAPRIL AND IN VITRO DISSOLUTION STUDIED

  • Liliya Logoyda Pharmaceutical Chemistry Department, Pharmaceutical faculty, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine.
  • Sergiy Kovalenko Organic and Bioorganic Chemistry Department, Zaporizhzhya State Medical University, Zaporizhzhya, Ukraine.
  • Ahmed M. Abdel-Megied Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Kafrelsheikh University, Kafrelshekh City, Egypt.
  • Igor Zhulkevych Oncology, Radiation Diagnostics and Therapy and Radiation medicine Department, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine.
  • Iryna Drapak General, Bioinorganic, Physical and Colloidal Chemistry Department, Danylo Halytsky Lviv National Medical University, Lviv City, Ukraine.
  • Inna Demchuk Pharmaceutical, Organic and Bioorganic Chemistry Department, Danylo Halytsky Lviv National Medical University, Lviv City, Ukraine.
  • Oleh Netsyuk L.Ya. Kovalchuk Department of Surgery, Urology, Minimally Invasive Surgery and Neurosurgery №1, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine.

Abstract

Objective: A simple, rapid and reproducible HPLC method was developed for the determination of bisoprolol in experimental combined dosage forms containing bisoprolol and enalapril and for drug dissolution studies.


Methods: A C18 column (Hi Qsil C18, 5 μm, 4.6х250 mm) and a mobile phase methanol: phosphate buffer solution (65:35, v/v) mixture were used for separation and quantification. Analyses were run at a flow rate of 1.0 ml/min and at ambient temperature. The injection volume was 300 μL and the ultraviolet detector was set at 225 nm. The method was validated as per ICH guidelines.


Results: Under these conditions, bisoprolol was eluted at 4.75 min. Total run time was shorter than 6 min. A linear relationship between the concentration and the area of ​​chromatographic peaks of bisoprolol in the range of 0.625 mg/ml-5.000 mg/ml (3.750 mg/ml at pH 1.2) has been established. In the medium with pH 1.2 release of bisoprolol from tablets in 5 min is 38.42%, and after 15 min-85.51%, in medium with pH 4.5 the release of bisoprolol from tablets in 5 min makes 59.78%, and after 15 min-103.71%; in a medium with pH 6.8, the release of bisoprolol from tablets in 5 min is 61.29%, and after 15 min-85.90%.


Conclusion: The developed method was applied successfully for quality control assay of bisoprolol in experimental tablets and in vitro dissolution studies.

Keywords: Bisoprolol, High performance liquid chromatography, Validation, Dissolution study

References

1. https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf [Last accessed on 01 Jan 2019]
2. Panainte AD. A HPLC method for the determination of bisoprolol in tablets and its application to a bioequivalence study. Revista De Chimie 2015;66:1791-5.
3. Arjun G. A simple HPLC method for quantitation of bisoprolol fumarate in tablet dosage form. Indian Drugs 2009;46:39–42.
4. 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.
5. 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.
6. Guidelines for validation of Analytical Procedures, Q2 (R1), ICH; 2005.
7. Yazdanian M, Briggs K, Jankovsky C, Hawi A. The "high solubility" definition of the current FDA guidance on biopharmaceutical classification system may be too strict for acidic drugs. Pharm Res 2004;21:293-9.
8. Srinivasan B, Kolli AR, Esch MB, Abaci HE, Shuler ML, Hickman JJ. TEER measurement techniques for in vitro barrier model systems. J Lab Autom 2015;20:107-26.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. Yuryeva O, Kondratova Y, Logoyda L. Development of high-performance liquid chromatography method for the simultaneous analysis of amlodipine and valsartan in combined dosage form and in vitro dissolution studies. Asian J Pharm Clin Res 2018;11:200-4.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. Shohin IE, Ramenskaya GV, Vasilenko GF, Malashenko EA. In vitro dissolution kinetics of amlodipine tablets marketed in russia under biowaiver conditions. Dissolution Technologies (august); 2010. p. 20-2.
Statistics
48 Views | 23 Downloads
How to Cite
Logoyda, L., Kovalenko, S., Abdel-Megied, A. M., Zhulkevych, I., Drapak, I., Demchuk, I., & Netsyuk, O. (2019). HPLC METHOD DEVELOPMENT FOR THE ANALYSIS OF BISOPROLOL IN COMBINED DOSAGE FORM CONTAINING BISOPROLOL AND ENALAPRIL AND IN VITRO DISSOLUTION STUDIED. International Journal of Applied Pharmaceutics, 11(3), 196-194. https://doi.org/10.22159/ijap.2019v11i3.32391
Section
Original Article(s)