Development and Validation of a HPLC Method for Simultaneous Analysis of Aspirin and Atorvastatin Calcium as the Bulk Drugs and in the Capsule Dosage Form

A simple, precise, accurate and rapid HPLC method has been developed, and validated for the determination of Aspirin, Atorvastatin Calcium simultaneously, in combined dosage form. Acetonitrile: 0.02 M Phosphate buffer with pH 6.1 (50%:50% v/v) is used as the mobile phase, pH adjusted with Sodium Hydroxide (1% aqueous). Mobile phase was delivered at the flow rate of 1.0 ml/min., 239 nm is the detection wavelength for this study. The applicability of the method for simultaneous determination of Aspirin, Atorvastatin Calcium was verified by the determination of these compounds in marketed capsules. Results of the analysis were validated statistically, and by recovery studies. Linearity for Aspirin And Atorvastatin Calcium was in the range of 5-35 μg/ml and 1-7 μg/ml, respectively and reproducibility was found to be satisfactory. The % assay (Mean±S.D.) was found to be 99.33±0.501 and 101.4±0.18 for Aspirin and Atorvastatin Calcium respectively. The recovery and RSD values are within the limits given in ICH guide lines. Method development indicates the suitability of proposed method for the routine determination of these compounds in capsule dosage form. The proposed method can be successfully used to determine the drug contents of marketed formulation.