ABSTRACT:
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.
Cite this article:
Siriki Pallavi, Gummadi Sowjanya. Quantification of Asciminib and its impurities: A RP-UPLC study. Research Journal of Pharmacy and Technology. 2024; 17(7):3430-6. doi: 10.52711/0974-360X.2024.00537
Cite(Electronic):
Siriki Pallavi, Gummadi Sowjanya. Quantification of Asciminib and its impurities: A RP-UPLC study. Research Journal of Pharmacy and Technology. 2024; 17(7):3430-6. doi: 10.52711/0974-360X.2024.00537 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-7-70
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