STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF ATORVASTATIN IN BULK DRUG, MARKETED TABLET AND NANOEMULSION FORMULATION

ABSTRACT A simple, highly sensitive, isocratic stability indicating reversed phase-high performance liquid chromatography (RP-HPLC) method with UV detection at 247 nm was developed and validated for analysis of atorvastatin (AT). Retention time of the AT was found to be 4.02 min. A mobile phase consisting of 0.05 M sodium phosphate buffer and methanol (3:7 v/v) pH 4.1 at flow rate of 1mL/min was employed in this study. The calibration curves were linear with regression coefficient (r 2 ) of 0.9997 ± 0.0014. The limits of detection (LOD) and the limits of quantification (LOQ) were found to be 0.20 and 0.60 μg/mL, respectively. The method was statistically validated in accordance with International conference on harmonization (ICH) guidelines. The proposed method was found sensitive, specific and was successfully applied for the estimation of atorvastatin in pharmaceutical formulations (bulk drug, tablet, nanoemulsion). Keywords: RP-HPLC; atorvastatin; nanoemulsion; tablets; ICH guidelines.