UV Derivative Spectrophotometric Method for Determination of Bisoprolol Fumarate in Bulk and Tablet Formulation
Elsadig H. Rudwan *
Amipharma Laboratories Ltd., Khartoum, Sudan
Amna B. W. E. Mohammed
Collège of Animal Production Science and Technology, Sudan University, Sudan
Ahmed E. M. Saeed
Department of Chemistry, College of Science, Sudan University of Science and Technology, Sudan
*Author to whom correspondence should be addressed.
Abstract
Simple, cost effective, accurate and reproducible UV derivative-spectrophotometric method were developed and validated for the estimation of bisoprolol fumarate in pharmaceutical preparations. Bisoprolol fumarate was estimated at 233 nm in 50% methanol. The beer’s law was obeyed in the concentration range of 2.0 –10.0 µg/ml (r2 = 0.9995). The apparent molar absorptivity and Sandall’s sensitivity coefficient were found to be 391 L· mol−1·cm−1 and 2.51-g·cm–2 /0.001 respectively, indicating the high sensitivity of the proposed method. The method was tested and validated for various parameters according to ICH guidelines. The detection and quantitation limits were found to be 0.0267 and 0.0808 μg /ml respectively. The proposed methods were successfully applied for the determination of bisoprolol fumarate in pharmaceutical preparations. The results demonstrated that the procedure is accurate, precise and reproducible (R.S.D. < 2%).
Keywords: Bisoprolol fumarate, UV-spectrophotometric method, first order derivative spectroscopy, assay