Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ATORVASTATIN (CALCIUM TRIHYDRATE) IN PHARMACEUTICAL DOSAGE FORMS

Abstract

An accurate, specific, linear, and sensitive reverse phase-HPLC method has been developed and validated for the determination of Atorvastatin (as calcium ) (ATOR) in pharmaceutical dosage form. The chromatographic separation was performed on end capped (Luna) C18 Column (250mm×4.6mm, 5μm particle size) using mobile phase A: (Methanol : Acetonitrile : 0.02M potassium dihydrogen phosphate with a pH adjusted to 6.85 with 5% w/v potassium hydroxide in distilled water, (45:45:10v/v) and mobile phase B: 0.02M potassium dihydrogen phosphate with a pH adjusted to 6.85 with 5% w/v potassium hydroxide in distilled water ) at a flow rate of 1.0 ml/min and ambient column temperature with the detection wavelength at 246nm. The retention times of ATOR was found to be about 8.25 min. The linearity was performed in the concentration range of 25.0-75.0 μg/ml with a squared correlation coefficient of 0.999. The percentage purity of ATOR was found to be >99.0%. The percentage recovery was determined for ATOR and was found to be 100.1%. The Proposed method has been validated for specificity, linearity, precision, accuracy, ruggedness and robustness which were within the acceptance limit according to ICH guidelines and the developed method was successfully employed for routine quality control analysis in the pharmaceutical dosage forms.

Keywords: Atorvastatin Calcium, RP-HPLC, Validation