DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF PITAVASTATIN CALCIUM IN BULK AND TABLET DOSAGE FORM

Abstract

An isocratic stability-indicating reverse phase high performance liquid chromatographic diode array detection method has been developed and validated for the quantitative determination of pitavastatin calcium in the presence of its degradation products. The chromatographic separation was achieved on Phenomenex Luna C18 column (250 X 4.0 mm id, 5μm) in the isocratic mode using acetonitrilemethanol- water (35:25:40, v/v/v, pH 3 adjusted with orthophosphoric acid) as mobile phase. The drug is subjected to different accelerated stress conditions and peaks of the degradation products were well resolved from the pure drug, which indicates the specificity and stability-indicating properties of the method. The method was linear (r= 0.9998) over the concentration range of 5-30 μg/mL. The proposed method was used to investigate the degradation kinetics of PTV in acidic condition at different temperatures. Degradation of pitavastatin followed first-order kinetics, and rate constant (k), half life (t1/2), time left for 90% potency (t90) and energy of activation were calculated.