ANALYTICAL METHOD VALIDATION OF ATORVASTATIN BY UV AND RP – HPLC METHOD

Abstract

The study presents the development and validation of analytical methods for the quantitative estimation of Atorvastatin, a widely prescribed HMG-CoA reductase inhibitor used in the treatment of hypercholesterolemia and the prevention of cardiovascular diseases. Two complementary analytical technique UV method and RP-HPLC were developed and validated in accordance with ICH guidelines. UV method involved measuring the absorbance of Atorvastatin at 246 nm using a methanol–water (9:1 v/v) solvent system. The method revealed excellent linearity within the concentration range of 5–30 µg/mL, with a correlation coefficient (r²) of 0.9994. Validation parameters including precision, accuracy, limit of detection, limit of quantitation, and robustness confirmed the method’s reliability. RP-HPLC method was optimized using a mobile phase of acetonitrile and 1% glacial acetic acid (70:30 v/v), with detection carried out at 254 nm. Chromatographic separation was achieved on a C18 column (250 × 4.6 mm, 5 µm), yielding a retention time of 4.4 minutes. This method demonstrated linearity over the range of 5–100 µg/mL, with a correlation coefficient (r²) of 0.9996.Both analytical methods proved to be highly sensitive, precise, and reproducible, confirming their suitability for the routine quality control analysis of Atorvastatin in pharmaceutical formulations. The validated procedures provide robust and reliable analytical tools to support regulatory compliance and ensure the quality assurance of pharmaceutical products containing Atorvastatin.