Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND VITAMIN D3 IN BULK AND TABLET DOSAGE FORM

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

ABSTRACT

A simple, specific and accurate (HPLC) High liquid chromatographic method was developed for the simultaneous estimation of Atorvastatin calcium and vitamin D3 in bulk and tablet dosage forms. The analysis has been performed by using Agilent Kinetex XB-C18 and mobile phase containing Methanol: acetonitrile (50:50% v/v) with distilled water at pH 2.5 adjusted with phosphoric acid. The detection was carried out at 252 nm with a flow rate of 1.0 ml/min. The retention time was 20 min. The method was validated according to ICH guidelines. The method was validated for specificity, precision, linearity, accuracy, limit of detection and limit of quantitation. The linearity for Atorvastatin calcium and Vitamin D3 were in the range of 50-150μg/ml and 25-75 μg/ml respectively. The recoveries of Atorvastatin calcium and Vitamin D3 were found to be in the range of 99.031% and 99.744% respectively. The proposed method was validated and successfully applied to the estimation of Atorvastatin calcium and Vitamin D3 in bulk and tablet dosage form.

Keywords: HPLC, Atorvastatin calcium, Theoretical plate, ICH etc.