Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF ATORVASTATIN CALCIUM IN BULK DRUG AND TABLET DOSAGE FORMS

Vijaya Lakshmi M.*, Vijaya Sri Ch. and Devala Rao Garikapati

ABSTRACT

A simple, accurate, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of atorvastatin calcium in bulk and tablet dosage forms. It was found that the excipients in the tablet dosage forms does not interfere in the quantification of active drug by the proposed method. The HPLC separation was carried out by reverse phase chromatography on RP-18C, Kinetex column (250×4.6mm) with a mobile phase consisting of 15mM Ammonium acetate pH 6: Acetonitrile (50:50) in gradient mode at a flow rate of 1ml/min. The detection is monitored at 246nm. The calibration curve for Atorvastatin calcium linear from 10 to 50μg/ml. The system and method precision were found to be within limits. The proposed method has been shown the adequate sensitivity, reproducibility and specificity for the determination of Atorvastatin calcium in bulk and its tablet dosage forms. LOD and LOQ for Atorvastatin calcium were found to be 0.952μg/ml and 2.88μg/ml. Accuracy (recoveries: 98-102%) and reproducibility were found to be satisfactory.

Keywords: Atorvastatin calcium; RP-HPLC Method; Reverse phase chromatography; Acetonitrile; Validation.