Background: Vildagliptin is a drug for the treatment of diabetes. DPP-IV inhibitor represents a new class of oral antihyperglycemic agents to treat patients with type 2 diabetes. Several RP-HPLC methods have been reported to determine Vildagliptin alone. However, it has been noted that there are no available stability-indicating methods in pharmacopeias (USP/BP/EP/JP) nor in the available literature to quantify known and unknown impurity patterns for vildagliptin in vildagliptin tablets.

Objective: The aim of this study is to develop a new single, sensitive, robust and specific gradient RP-HPLC method to quantify known and unknown impurities and degradants of Vildagliptin in Vildagliptin tablets.

Methods: Chromatographic separation has been accomplished on the Hypersil ODS column (250 x 4.6) mm, 5 μm with a mobile phase consisting of a mixture of Perchloric acid Buffer, methanol, acetonitrile and Triethylamine delivered at a flow rate of 1.0 mL minute^-1 and the detection wavelength 210 nm. The developed method was validated as per ICH guidelines.

Results: Vildagliptin was found degraded significantly under oxidative and alkaline stress conditions. The degradation products were well resolved from Vildagliptin and its impurities. An analytical method was found linear, accurate and precise from LOQ (Limit of Quantification) level to 150% of impurity specification limit (0.5%).

Conclusion: The method found sensitive, rapid and accurate quantification of known, unknown impurities and degradants. The peak purity results confirmed that the Vildagliptin peak was homogeneous and pure in all stress samples, thus proving the stability-indicating nature of the method.

背景：维格列汀是一种治疗糖尿病的药物。DPP-IV 抑制剂代表了一类用于治疗 2 型糖尿病患者的新型口服降糖药。已经报道了几种 RP-HPLC 方法可以单独测定维格列汀。然而，已经注意到药典 (USP/BP/EP/JP) 和现有文献中都没有可用的稳定性指示方法来量化维格列汀片剂中维格列汀的已知和未知杂质模式。

目的：本研究的目的是开发一种新的单一、灵敏、稳健和特定的梯度 RP-HPLC 方法，以量化维格列汀片中已知和未知的维格列汀杂质和降解物。

方法：在 Hypersil ODS 色谱柱 (250 x 4.6) mm，5 μm 上完成色谱分离，流动相由高氯酸缓冲液、甲醇、乙腈和三乙胺的混合物组成，流速为 1.0 mL min ^-1检测波长210 nm。根据 ICH 指南对开发的方法进行了验证。

结果：发现维格列汀在氧化和碱性应激条件下显着降解。降解产物与维格列汀及其杂质分离良好。发现从 LOQ（定量限）水平到杂质规格限的 150% (0.5%) 的分析方法是线性、准确和精确的。

结论：该方法可以灵敏、快速和准确地定量已知、未知杂质和降解物。峰纯度结果证实维格列汀峰在所有应力样品中均一纯正，从而证明了该方法的稳定性指示性质。