Abstract

Parmar Aditi, Dr. Bhumi R. Patel*, Dr. Jaymin G. Patel, Mr. Ronak N. Patel, Ms. Pooja Soni, Dr. Divyakant Patel

ABSTRACT

A Novel, simple, precise, specific, accurate and rapid Reversed Phase HighPerformance Liquid Chromatographic (RP-HPLC) method for estimation ofIvosidenib Impurity 1, Ivosidenib API has been developed and validated. Theseparation was achieved by employing column Agilent zorbax C18 (250 mm × 4.6mm × 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 keptat 237 nm, 248 nm using PDA detector, temperature was kept at 25°C. Retentiontime was noted to be 7.378 min, 19.690 min for Ivosidenib impurity 1, IvosidenibAPI respectively. The various analytical validation parameters, includingspecificity, linearity, LOD, LOQ, precision, accuracy, and robustness weredetermined as per ICH Q2(R2) guidelines. The method was linear over the range of50-100 μg/ml, 200-600 μg/ml, for Ivosidenib impurity 1, Ivosidenib APIrespectively. Hence, the developed RP-HPLC method was found to be specific,accurate, precise, and robust for estimation of Ivosidenib Impurity 1 and IvosidenibAPI.