Manish Gangrade Author

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Stability Indicating High Performance Liquid Chromatographic Method for Linagliptin and Mechanistic Identification of its Degradants using LC-MS

Author(s):

Manish Gangrade, Jai V Sapre, Hemkant P Gharat, Sagar D More, Rosebelle T Alexander, Shweta S Shinde and Nitesh S Kanyawar

A selective, precise and reproducible reverse phase-High Performance Liquid Chromatographic method was developed and validated for Linagliptin drug substance. Using this method separation of eight potential process related impurities, comprising 3 isomeric compounds of linagliptin (concentration range of 0.25- 0.75 µg/ mL) and its impurities was achieved. The chemical stability of linagliptin was determined by forced degradation under thermal, acidic, oxidative, basic and hydrolytic conditions and subsequently eight degradants were assigned a structure by LCMS/MS. Linagliptin degraded significantly under oxidation because of the formation of four types of N-oxides in considerable amount as compared to Linagliptin. In this study the mechanistic pathway ... view more»

DOI: 10.4172/2325-9604.1000156

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