Abstract

Charles Brown, Edmund Browne and Bernard Lawson

A simple, selective, precise and stability-indicating high-performance liquid chromatographic (HPLC) method of analysis of Atorvastatin Calcium in pharmaceutical dosage form was developed and validated. The chromatographic conditions comprised of a reversed-phase C18 column (250 x 4.6 mm), 5 μ with a mobile phase consisting of a mixture of Methanol: Acetonitrile: Phosphate Buffer solution in the ratio (45:45:10). Flow rate was 1 mL / min. Detection was carried out at 246 nm. The retention time of Atorvastatin was 6.98 min. Atorvastatin Calcium was subjected to acid and alkali hydrolysis, oxidation, photochemical degradation and thermal degradation. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range 52.20 to 156.60 μg/mL. The value of correlation coefficient, slope and intercept were, 0.9999, 36.02 and 26.45, respectively. The method was validated for precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, photochemical and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.