METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF PITAVASTATIN IN API FORM AND MARKETED TABLET DOSAGE FORM BY RP-HPLC

ABSTRACT

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Pitavastatin in bulk form and marketed formulation. Separation of Pitavastatin was successfully achieved on a Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.e. column in an isocratic mode of separation utilizing Methanol: Phosphate buffer (0.02M, pH3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Pitavastatin. The correlation coefficient was found to be 0.9995 for Pitavastatin. The LOD and LOQ for Pitavastatin were found to be 5.004μg/mL and 15.164μg/mL respectively. The proposed method was found to be a good percentage recovery for Pitavastatin, which indicates that the proposed method is highly accurate. The specificity of the method shows a good correlation between the retention times of the standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Keywords: Pitavastatin, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines