Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India
A simple isocratic RP-UPLC-PDA detection method was developed for Asciminib and its process-related impurities. The chromatographic separation of Asciminib and its related impurities was achieved on the Agilent Eclipse C18 (150 × 4.6 mm, 3.5 μ) column with 0.1 percent v/v formic acid and acetonitrile (50:50 v/v) as a mobile phase at a flow rate of 1.0 mL/min. over a 5 min. run time analysed at 232 nm. The proposed method was validated according to the International Council for Harmonization (ICH) guidelines. The linearity was established from 75.00 - 450.00 μg/mL (Asciminib), 2.50 - 15.00 μg/mL (ASC Imp-1, ASC Imp-2) and 1.25 -7.50 μg/mL (ASC Imp-3) with regression coefficient > 0.999. The respective computed LOD and LOQ values were 3.0, 10.0 μg/mL for Asciminib, 1.0, 3.0 μg/mL for both Imp-1 & Imp-2 and 0.5, 1.5 μg/mL for Imp-3. The method was further studied for forced degradation.
RP-UPLC, PDA, Asciminib, Process-related impurities, Validation, Degradation
