RP-HPLC METHOD FOR ESTIMATION OF ROSUVASTATIN CALCIUM FROM BULK AND TRANSDERMAL DOSAGE FORM

A RP-HPLC method was developed for estimation of rosuvastatin calcium and validated as per ICH guidelines. The estimation was carried out on C-18 Reliant (4.6 × 250 mm, 5 µm) column using a filtered and degassed mixture of acetonitrile: phosphate buffer pH 2.6 (in the ratio 70:30) as the mobile phase at a flow rate of 1.0 ml/min. The detection was carried out at wavelength of 241 nm. The method was validated for linearity, specificity, accuracy, precision, sensitivity and robustness as per ICH norms. The retention time for the drug was 3.35 min. The method produced linear responses in the concentration range of 2-20 μg/ml with correlation coefficient (r²) of 0.998. The method developed was found to be simple, rapid, precise accurate and reproducible and can be used for routine analysis of rosuvastatin calcium. Diffusion procedure was performed using pig ear skin as diffusion barrier to characterize rosuvastatin calcium release rate from drug -in -adhesive patch and further analyzed by developed RP–HPLC method. The validated method was found to be specific for estimation of rosuvastatin calcium from its transdermal dosage form. The short run time and the possibility of analysis of a large number of samples makes it a suitable method for analysis and quality control of pharmaceutical preparations containing rosuvastatin calcium.