Development and validation of analytical method for clopidogrel bisulphate and irbesartan by simultaneous equation spectroscopic method

Abstract

Objective: The major approach take into consideration is to develop a simple, accurate, precise and reproducible method for development and validation of UV-visible spectrophotometric method for estimation of Clopidogrel Bisulphate and Irbesartan in synthetic mixture. Methods: In linearity spectra of the Clopidogrel Bisulphate and Irbesartan to shows to possible a simultaneous equation method but the zero order linearity spectra was converted to first derivative and second derivative spectroscopic method to not shows any zero crossing point so that this method was not possible. Results: In this spectroscopic method, for Clopidogrel Bisulphate 220 nm and 250 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 λ max with correlation coefficient (r 2 ) 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 0.056 μg/ml and 0.075 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. The limit of quantification was 0.172 μg/ml and 0.229 μg/ml for Clopidogrel Bisulphate and Irbesartan, respectively. Recovery of Clopidogrel Bisulphate and Irbesartan were found to be 99.58% and 99.66% respectively confirming the accuracy of the proposed method.  % Assay was found to be 99.41% and 99.22% for Clopidogrel Bisulphate and Irbesartan, respectively. Conclusions: It can be concluded from the study that assay results obtained by proposed method are in fair agreement and can be effectively applied for the estimation of these two drugs.