Design of Optimized RP-HPLC Method for Quantitative Analysis of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Form

Abstract

In this study an effective method was developed to assay Bisoprolol fumarate in tablets dosage form. The chromatographic separation was achieved on Reprosil pure basic C18 analytical column. A mixture of acetonitrile + Potassium dihydrogen phosphate buffer (0.050 mol L-1) (30:70 V/V), pH 3.5 was used as the mobile phase, effluent flow rate monitored at 1.0 mL/min, and UV detection at 233 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature which were investigated showed no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 5µg/mL to 17.5µmg/mL, precise (intra- and inter-day relative standard deviations R.S.D. < 2 %), (r2 = 0.9995).