A New Validated Analytical Method For Simultaneous Estimation Of Trimetazidine Dihydrochloride And Bisoprolol Fumarate From Dosage Forms Using HPLC

Abstract

Developed and validated analytical method which simultaneously estimate both the drugs Trimetazidine dihydrochloride and Bisoprolol Fumarate in Bulk drug and formulations in single method.  This method developed on HPLC and it is very simple, precise and accurate. Separation of both drugs achieved using a C18 column Gemini 4.6 x 50 mm, 3µ. Mixture of pH 6.8 Ammonium fumarate solution and Acetonitrile in the ratio 80:20 v/v used as Mobile phase. The flow rate was 0.8 mL/min and selected wavelength was 272 nm. Linearity covered for Bisoprolol fumarate and Trimetazidine dihydrochloride in the range of 0.25-0.75 mg/mL and 4-12 mg/mL respectively. Using this method analysed the Marketed samples and observed Assay are 98.8% and 99.0% for Trimetazidine dihydrochloride and Bisoprolol fumarate respectively. According to International Conference on Harmonization (ICH) guideline method was validated. The proposed method is very easy and cost effective.