分析および生物分析技術ジャーナル

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

Chaitali Dhale and Janhavi R Rao

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