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Stability Indicating HPLC MS Method for Determination of Degradation Products in Vildagliptin

Chaitali Dhale^1* and Janhavi R Rao²

¹Department of Quality Assurance, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune-411038, Maharashtra, India

²Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune-411038, Maharashtra, India

Received Date: Sep 17, 2019 / Accepted Date: Sep 27, 2019 / Published Date: Oct 10, 2019

Citation: Dhale C, Rao JR (2019) Stability Indicating HPLC MS Method for Determination of Degradation Products in Vildagliptin. J Anal Bioanal Tech 10: 420.

Copyright: © 2019 Dhale C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Vildagliptin is an anti-diabetic drug under new class of dipeptidyl peptidase-4(DPP-4) inhibitor. The proposed work is performed to develop simple reverse phase liquid chromatographic method for force degradation behavior of Vildagliptin and its degradation pattern in pharmaceutical dosage forms. The chromatographic separation was obtained on C18 column with mobile phase containing acetonitrile and water (40:60) pH adjusted at 7.0 using triethylamine, with a flow rate of 1 ml/min, UV detection at 220 nm. Retention time was found to be 5.3 min and method was linear in the range of 2-12 ug/ml of R2=0.9999. Limit of detection and limit of quantization were 3.61 and 10.96 ug/ml, respectively.

The method was validated in accordance with International Conference on Harmonization Q2 (R1). Stress studies were carried out using acidic, basic, oxidative, thermal and photolytic conditions and there is no interference of the degradation products was observed with main drug peak

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