Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND CLOPIDOGREL BISULPHATE IN BULK AND TABLET DOSAGE FROM

Ashwini R. Patil*, Prajkta M. Ghagare, Bhavna J. Deshmane and Manish S. Kondawar

ABSTRACT

A simple, rapid, reliable and precise High performance liquid chromatography method has been developed and validated for simultaneous estimation of Atorvastatin calcium (ATOR) and Clopidogrel bisulphate (CLOP) from tablet dosage from. Chromatography was carried out at 300C Kinetex XB C18 column with gradient mobile phase methanol and water (50:50) at a flow rate 0.8ml/min. the detection was carried out at 220nm. The total run time 20min. The method was validated guidelines and the acceptance criteria for accuracy, precision, linearity, specificity were method in all cases. The calibration plot of peak area against concentration was liner in the range 5-15μg/ml for ATOR and 48.75-146.25μg/ml CLOP. Limit of detection obtained were 1.17μg/ml for ATOR, 12.01μg/ml for CLOP and limit of quantification 3.54μg/ml for ATOR and 36.39μg/ml for CLOP. The proposed method can be used for the estimation of these drugs in combined dosage forms.

Keywords: High performance liquid chromatography (HPLC), Atorvastatin calcium (ATOR). Clopidogrel Bisulphate (CLOP), limit of detection, limit of quantification.