Development and Validation of Analytical Method for Clopidogrel Bisulphate and Irbesartan by Simultaneous Equation Spectroscopic Method

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Clopidogrel Bisulphate and Irbesartan in synthetic mixture using simultaneous equation Method. In this spectroscopic method, for Clopidogrel Bisulphate 220.00 nm and 250.00 nm wavelengths were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 10–50 μg/ml at their respective λmax with correlation coefficient (r2) of 0.9996 and 0.9998 for Clopidogrel Bisulphate and Irbesartan, respectively. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (< 2%). The limit of determination was 0.243 μg/ml and 0.323 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. The limit of quantification was 0.737 μg/ml and 0.980 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. Recovery of Clopidogrel Bisulphate and Irbesartan were found to be 99.57% and 99.68% respectively confirming the accuracy of the proposed method. % Assay was found to be 99.41% and 99.22% for Clopidogrel Bisulphate and Irbesartan, respectively. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.