PRECISE AND ACCURATE UV-SPECTROPHOTOMETRIC ESTIMATION OF ATORVASTATIN IN BULK AND DOSAGE FORM: A VALIDATION STUDY

The present study aimed to develop and validate a simple, precise, and accurate UV spectrophotometric method for the estimation of atorvastatin in bulk and pharmaceutical dosage forms. The method exhibited excellent linearity over the concentration range of 20–120 µg/ml with a correlation coefficient (R²) of 0.9996 and a regression equation of y = 0.01x + 0.0048. Precision was confirmed through intra-day and inter-day studies, showing low %RSD values of 0.2598 and 0.2987, respectively. Accuracy, evaluated via recovery studies at 80%, 100%, and 120% concentration levels, yielded a mean recovery of 99.65% ± 1.25, demonstrating the method’s reliability. The method also proved sensitive with a Limit of Detection (LOD) of 0.19872 µg/ml and a Limit of Quantification (LOQ) of 0.652387 µg/ml. Specificity studies confirmed no interference from formulation excipients. Additional parameters, including molar absorptivity (2289.23) and Sandell’s sensitivity (0.125), further validated the method’s robustness. The results affirm that this UV spectrophotometric method meets ICH validation criteria and is suitable for routine quality control of atorvastatin.