Quality-by-Design-Driven RP-HPLC Method Development and Validation for Impurity Analysis of Elexacaftor, a Cystic Fibrosis Drug, with LC-MS/MS-Based Degradant Identification.

ABSTRACT: The development and validation of an analytical technique based on RP-HPLC for the determination of impurities in Elexacaftor (ELX). Using a straightforward and stability-indicating HPLC technique, six known contaminants were precisely assessed with the right resolutions and peak forms. In a number of separation studies, the chromatographic separation was accomplished using an XBridge Shield RP 18, 150 mm × 4.6 mm, 3.5 μm column. The mobile phases consisted of methanol, acetonitrile, 2-propanol, and 10 mM potassium dihydrogen orthophosphate buffer used for the analysis. The gradient elution process took 90 min to complete, and the column temperature was 27 °C. Photodiode array optimization was accomplished at 220 nm with a 0.7 mL/min flow rate. The developed procedure was validated followi

SUBMITTER: Raghupathi JK 

PROVIDER: S-EPMC12509017 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature