Journal of Pharmaceutics & Drug Delivery Research ISSN: 2325-9604

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Research Article, J Pharm Drug Deliv Res Vol: 5 Issue: 6

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

Manish Gangrade, Jai V Sapre, Hemkant P Gharat, Sagar D More, Rosebelle T Alexander, Shweta S Shinde and Nitesh S Kanyawar*
CIPLA Limited, L.B.S. Marg, Vikhroli (W), Mumbai-400 083, India
Corresponding author : Nitesh S Kanyawar
Department of Pharmacy, CIPLA Limited, L.B.S. Marg, Vikhroli (W), Mumbai-400 083, India
Tel: +91 9819277642, +9122-2575 6088
E-mail: [email protected]
Received: September 23, 2016 Accepted: December 14, 2016 Published: December 19, 2016
Citation: Gangrade M, Sapre JV, Gharat HP, More SD, Alexander RT, Shinde SS, et al. (2016) Stability indicating High Performance Liquid Chromatographic Method for Linagliptin and Mechanistic Identification of its Degradants using LC-MS. J Pharm Drug Deliv Res 5:6. doi: 10.4172/2325-9604.1000156

Abstract

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 of all degradation routes have been elaborated. The findings of this study may assist in formulation development.

Keywords: Linagliptin; Stability indicating; Degraded impurities; Validation; High performance liquid chromatography

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