DEVELOPMENT AND VALIDATION OF ANALYTICAL RP-HPLC METHOD FOR THE ANALYSIS OF PITAVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

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Dr. Subhas Sahoo, Dr.D.Varun, V.Kranthi Rekha, Dr.S.Srinivasa Rao

A recently developed RP-HPLC method allows for the simple and precise measurement of pitavastatin in both bulk sources and commercially available pharmaceutical dosage forms. For the chromatographic runs, the mobile phase was prepared by mixing one part acetonitrile and seventy percent phosphate buffer (0.01M, pH-3.2). A tchromatographic separation was achieved using an isocratic mode and a SymmetryC18 ODS column with dimensions of 4.6mm × 250mm and a particle size of 5µm. The drug peaks at 246 nm were detected by a UV detector and were clearly separated. The length of pitavastatin’s retention time was found to be 5.404 minutes. Within the concentration range of 6-14 μg/ml, the developed method demonstrated linearity for pitavastatin. Following ICH guidelines, the method has been tested for system suitability, specificity, accuracy, and robustness. Pitavastatin had a limit of quantification (LOQ) of 1.477 μg/ml and a limit of detection (LOD) of 0.487 μg/ml.

Accuracy, precision, robustness, RP-HPLC, pitavastatin and ICHguidelines.