Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION OF ATORVASTATIN AND ASPIRIN

Piyush Kashyap* and Amit Aggarwal

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Abstract

In accordance with the guidelines of the International Conference on Harmonization (ICH), a new, straightforward, innovative, accurate, precise, dependable, fast, and linear reverse phase high-performance liquid chromatography (RP-HPLC) method was created and thoroughly validated for the simultaneous qualitative and quantitative estimation of atorvastatin and aspirin in bulk and pharmaceutical dosage form. Validation by HPLC method, the wavelength was selected at the isobestic point at which the two drugs can be detected using UV detectors. The selected wavelength was 255 nm. Using anorthophosphoric acid-adjusted methanol (20:80) mobile phase that contained 0.02 M potassium dihydrogen phosphate, a phenomenex C- 18, 5 μm column with 250 x 4.6 mm i.d. in isocratic mode was employed. The effluents were measured at 255 nm, and the flow rate was 1.0 ml/min, Linearity range was determined by external standard calibration method in the concentration range of 20μg/mL to 120μg/mL for atorvastatin and aspirin's acid hydrolysis yielded degradation rates of 2.15% and 2.19%, respectively, after one hour at 60°C. Atorvastatin and aspirin's basal hydrolysis amounts for one hour at 60°C were 2.69% and 1.98%, respectively. At normal temperature, the amounts of oxide degradation of aspirin and atorvastatin were 3.86% and 7.56%, respectively, after three hours. Aspirin and atorvastatin's respective amounts of thermal degradation after a 5-hour period at 110°C were 0.99% and 0.90%.

Keywords: Simultaneous estimation, Atorvastatin, Aspirin, and RP-HPLC.