RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IVOSIDENIB IMPURITY 1

A Novel, simple, precise, specific, accurate and rapid Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) method for estimation of Ivosidenib Impurity 1, Ivosidenib API has been developed and validated. The separation was achieved by employing column Agilent zorbax C18 (250 mm × 4.6 mm × 5 µm) as a stationary phase, In gradient program mixture of Mobile phase A: 0.1% Formic acid: methanol: IPA:GAA(60:35:5:0.5v/v/v/v) Mobile phase B: Phosphate buffer pH 5 at a flow rate of 1.0 mL/min. Detection wavelength was kept at 237 nm, 248 nm using PDA detector, temperature was kept at 25°C. Retention time was noted to be 7.378 min, 19.690 min for Ivosidenib impurity 1, Ivosidenib API respectively. The various analytical validation parameters, including specificity, linearity, LOD, LOQ, precision, accuracy, and robustness were determined as per ICH Q2(R2) guidelines. The method was linear over the range of 50-100 µg/ml, 200-600 µg/ml, for Ivosidenib impurity 1, Ivosidenib API respectively. Hence, the developed RP-HPLC method was found to be specific, accurate, precise, and robust for estimation of Ivosidenib Impurity 1 and Ivosidenib API.