A Novel Method Development and Validation by Ultra-Performance Liquid Chromatography for Assay of Asciminib in Dosage Form

Abstract

The main objective of the present study was to develop and validate simple, precise, sensitive and accurate UPLC method for the estimation of asciminib in pure and dosage form. The UPLC method was developed by using Waters Acquity liquid chromatographic system and Zorbax Phenyl (100x1.0mm,1.7µm) column. The developed method was validated according to the international conference on harmonization (ICH) guidelines. The chromatographic separation of asciminib with good resolutions has been achieved by using the mobile phase acetonitrile: ammonium dihydrogen phosphate buffer (20:80 v/v) at a flow rate of 0.5 mL/min, injection volume of 5 µL, and at 242 nm wavelength. The validated method was found to be linear in the range of 4 - 60 µg/mL. The limit of detection (LOD) and limit of quantification (LOQ) for asciminib were found to be 0.4 and 0.12 µg/mL respectively. The % RSD was found to be less than 2 % revealing the precision of the developed method. Besides, the recovery rate was observed close to 100 % confirming the accuracy of the method. Minor alterations in the chromatographic conditions have revealed robustness and ruggedness of the developed method. The developed analytical method is simple, precise, sensitive, and reproducible which can be used for the estimation of asciminib.