European Journal of Chemistry

Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC

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Published: Mar 31, 2019
DOI: https://doi.org/10.5155/eurjchem.10.1.52-56.1815
Keywords:
Tablets, RP-HPLC, Bisoprolol, Rosuvastatin, Chromatography, Novel formulation
Section
Research Article
Issue
Vol. 10 No. 1 (2019): March 2019
Dates
Received 2018-11-20
Accepted 2018-12-18
Published 2019-03-31
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Main Article Content

Marco Mounir Zaki
Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
http://orcid.org/0000-0001-8379-6865
Nada Sayed Abdelwahab
Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
http://orcid.org/0000-0002-0700-7542
Adel Ahmed Ali
Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
http://orcid.org/0000-0002-1328-5987
Souty Mounie Zaki Sharkawi
Pharmacology and Toxicology, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, Egypt
http://orcid.org/0000-0002-4662-5917

Abstract

A simple, specific, and precise RP-HPLC method was developed and validated for simultaneous determination of Bisoprolol fumarate (BIS) and Rosuvastatin calcium (ROS) in new formulated tablets. The developed RP-HPLC method depended on chromatographic separation using C18 column (150×4.6 mm, 0.5 μm) with mobile phase consisted of acetonitrile and 0.05 aqueous solution of orthophosphoric acid at the ratio of 65:35 % (v:v) with a flow rate of 1 mL/min and UV detection was carried out at 230 nm. Factors affecting the developed methods were studied and optimized and the retention times for BIS and ROS were found to be 2.758 and 4.974 min, respectively. Linearity of the proposed method was observed over a concentration range 0.2-50 μg/mL for each of BIS (r = 0.9999) and ROS (r = 0.9998). The proposed method was successfully applied for the determination of the studied drugs in their bulk powder, laboratory prepared mixtures and in the formulated tablets. The developed method is the first chromatographic method for determination of those drugs and showed no significant difference when compared with the reported methods.


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Zaki, M. M.; Abdelwahab, N. S.; Ali, A. A.; Sharkawi, S. M. Z. Simultaneous Determination of Bisoprolol Fumarate and Rosuvastatin Calcium in a New Combined Formulation by Validated RP-HPLC. Eur. J. Chem. 2019, 10, 52-56.

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