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

Authors : Pridhvi Krishna GADDEY, Raja SUNDARARAJAN

Pages : 529-540

Doi:10.18596/jotcsa.1228364

View : 30 | Download : 65

Publication Date : 2023-05-31

Article Type : Research Paper

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 insert ignore into journalissuearticles values(100x1.0mm,1.7µm); column. The developed method was validated according to the international conference on harmonization insert ignore into journalissuearticles values(ICH); guidelines. The chromatographic separation of asciminib with good resolutions has been achieved by using the mobile phase acetonitrile: ammonium dihydrogen phosphate buffer insert ignore into journalissuearticles values(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 insert ignore into journalissuearticles values(LOD); and limit of quantification insert ignore into journalissuearticles values(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.
Keywords : UPLC, Asciminib, Buffer, Method development, Forced degradation studies