Method Development and Validation of Stability indicating HPLC method used for the estimation of Degradation Products of Atorvastatin Calcium

A simple, fast and precise gradient reversed phase high performance liquid chromatographic method was developed for the estimation of impurities and degradation products of the Atorvastatin Calcium and validated as per ICH guidelines. The drug substance, its impurities and degradation products were found well separated with gradient conditions having short run time of 35 mins by using Symmetry C18 column from Water’s (250 x 4.6 mm, 5μm). The flow rate was kept 1 mL/min. The gradient mobile phase consisted of A= 0.05% Trifluoroacetic acid in water and B= 0.05% Trifluoroacetic acid in Acetonitrile. Detection was performed at 249 nm using PDA detector.

The method was validated for Specificity, LOD, LOQ, Linearity and Accuracy as per ICH guidelines. The stability indicating capability of the method was established by performing forced degradation study. The proposed method was found to be accurate, precise and fast for the estimation of Atorvastatin, its impurities and degradation products.