Stability Indicating RP-HPLC Method for the Estimation of Olutasidenib in Bulk Pharmaceutical Formulations

Abstract

A simple, rapid, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Olutasidenib in pharmaceutical dosage form. Chromatographic separation of Olutasidenib was achieved on a Waters Alliance e-2695 HPLC, using a Symmetry C18 150 x 4.6 mm, 3.5 µm column, and the mobile phase containing 1 mL OPA dissolved in 1 L water and ACN in a ratio of 70:30% v/v. The flow rate was 1.0 mL/min; detection was carried out by absorption at 218 nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Olutasidenib were NLT 2000 and should not be more than 2, respectively. The limit of detection (LOD) was 0.3 µg/mL with a signal-to-noise ratio (S/N) of 3, and the limit of quantification (LOQ) was 1.0 µg/mL with an S/N of 10. Precision was tested through intra-day and inter-day studies, with % RSD values consistently below 2%, confirming repeatability and precision. The relative standard deviation (RSD) of peak areas from all measurements was always less than 2.0%. The stability of Olutasidenib was assessed under various stress conditions, including acidic, alkaline, oxidative, thermal, photolytic, and hydrolytic environments. All samples met the acceptance criteria for purity angle, purity threshold, and degradation percentage, demonstrating that Olutasidenib is stable under these conditions and passes the test. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate, and robust for quantitative analysis of Olutasidenib.