Stress‐Induced Degradation Profiling of Evogliptin by Stability‐Indicating Reversed‐Phase High‐Performance Liquid Chromatography and Liquid Chromatography–Mass Spectrometry

A stability‐indicating reversed‐phase high‐performance liquid chromatographic method was developed and validated for quantitative determination of evogliptin in bulk drug substance and a marketed tablet formulation, followed by supporting liquid chromatography‐mass spectrometry investigation of selected stress‐associated components. Separation was achieved on an Eclipse XDB C8 column (250 × 4.6 mm, 5 μm) using acetonitrile and 0.1% formic acid in water (80:20, v/v) at 1.0 mL/min, with photodiode‐array detection at 268 nm and a 10 min run time. The method was linear over 10–60 μg/mL ( R 2 = 0.9993), with repeatability and intermediate precision below 2%. Mean recoveries ranged from 99.657 to 100.555%. The marketed tablet assay was 100.161 ± 0.333%. Forced‐degradation studies showed parent‐drug response losses of 10.90%, 23.61%, and 9.08% under acidic hydrolysis, alkaline hydrolysis, and oxidative stress conditions, respectively. Thermal and photolytic solid‐state exposure produced only 0.40% and 0.08% response loss, respectively, under the conditions investigated. Full‐scan LC–MS showed ions at m/z 186.2, 363.3, and 417.4 associated with DP1, DP2, and DP3, respectively. These findings support stress association but not definitive structures, as product‐ion MS/MS, accurate‐mass measurements, and authentic degradation‐product standards were not used. This study integrates quantitative stability‐indicating chromatographic assessment with conservative mass‐spectrometric investigation of selected stress‐associated components.