DEVELOPMENT AND VALIDATION OF HPLC-DAD METHOD FOR THE DETERMINATION OF BISOPROLOL IN TABLET DOSAGE FORMS


Yuliya Kondratova, Liliya Logoyda, Yuliia Voloshko, Ahmed Abdel Megied, Dmytro Korobko, Yuriy Soroka

Abstract


Objective: A rapid, simple and sensitive RP-HPLC method was developed and validated for the determination of bisoprolol fumarate in bulk and pharmaceutical dosage form.

Methods: Chromatographic separation was achieved within 2.5 min on ACQUITY Arc System, Waters Symmetry C18 column (3.9 mm i.d. X 150 mm, 5 μm particle sizes) using a mobile phase consisted of acetonitrile: phosphate buffer (25:75 v/v) in an isocratic mode at a flow rate of 1.4 ml/min. The pH of the mobile phase was adjusted to 7.0 with orthophosphoric acid and UV detection was set at 226 nm.

Results: The retention time for bisoprolol fumarate was found to be 2.09 min. The proposed method was validated according to ICH guidelines with respect to linearity, specificity precision, accuracy and robustness. The limit of detection and limit of quantification are calculated and found to be 0.4825 and 1.4621 μg/ml; respectively.

Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.

Keywords: Bisoprolol, High-Performance Liquid Chromatography, Validation, ICH guidelines


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About this article

Title

DEVELOPMENT AND VALIDATION OF HPLC-DAD METHOD FOR THE DETERMINATION OF BISOPROLOL IN TABLET DOSAGE FORMS

DOI

10.22159/ijap.2017v9i6.21616

Date

08-11-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 6 (Oct-Nov), 2017 Page: 54-59

Online ISSN

0975-7058

Statistics

17 Views | 14 Downloads

Authors & Affiliations

Yuliya Kondratova
Central R&D Laboratory JSC Farmak, Kyiv City Ukraine
Ukraine

Liliya Logoyda
Pharmaceutical Chemistry Department, Pharmaceutical faculty, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine

Yuliia Voloshko
Central R&D Laboratory JSC Farmak, Kyiv City Ukraine

Ahmed Abdel Megied
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy and Pharmaceutical Manufacturing, Kafrelsheikh University, Kafrelsheikh City, Egypt

Dmytro Korobko
Pharmaceutical Chemistry Department, Pharmaceutical faculty, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine

Yuriy Soroka
Department of Anaesthesiology and Intensive-Care Medicine, I. Horbachevsky Ternopil State Medical University, Ternopil City, Ukraine


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