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

Liliya Logoyda; Sergiy Kovalenko; Ahmed M. Abdel-Megied; Igor Zhulkevych; Iryna Drapak; Inna Demchuk; Oleh Netsyuk

doi:10.22159/ijap.2019v11i3.32391

Authors

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.

DOI:

https://doi.org/10.22159/ijap.2019v11i3.32391

Keywords:

Bisoprolol, High performance liquid chromatography, Validation, Dissolution study

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 C₁₈column (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.

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