Vildagliptin (VLG) corresponds to a drug used for the treatment of diabetes mellitus. This disease requires continuous treatment, and so the control of impurities present in it is important to assure the quality of this drug. Thus, it is necessary to use sensitive and selective detection techniques and the ultra-performance liquid chromatography is a better option compared with high-performance liquid chromatography because it enhances the separation efficiency with a shorter analysis time and an increased resolution. This research analysis was accomplished by using liquid chromatography/tandem mass spectrometry, and the quantification was performed by using an extracted ion from the VLG drug and its main organic impurities of synthesis. During the validation process, following international standards, the method proved to be linear for the tree substances (R² = 0.997–0.998) and the analysis of variance showed a non-significant linearity deviation (P > 0.05). Three critical factors were selected to evaluate method robustness with a full factorial experimental design, and the changes in the parameters were found to be not significant for the quantification of VLG and its impurities. The ultra-performance liquid chromatography-tandem mass spectrometry for the determination of impurities in VLG was precise, accurate and robust proving to be effective for analysis in the pharmaceutical industry and to improve the quality, safety and effectiveness of the new drug developed.

中文翻译：

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UPLC-ESI / Q-TOF MS / MS方法测定维格列汀及其有机杂质

维格列汀（VLG）对应于用于治疗糖尿病的药物。这种疾病需要持续治疗，因此控制其中存在的杂质对于确保这种药物的质量非常重要。因此，有必要使用灵敏的选择性检测技术，与高效液相色谱法相比，超高效液相色谱法是更好的选择，因为它可以提高分离效率，并缩短分析时间并提高分离度。通过液相色谱/串联质谱法完成这项研究分析，并使用从VLG药物及其合成的主要有机杂质中提取的离子进行定量分析。在验证过程中，遵循国际标准，²  = 0.997–0.998），方差分析显示线性差异不显着（P>  0.05）。选择了三个关键因素以通过全因子实验设计来评估方法的鲁棒性，并且发现参数的变化对于VLG及其杂质的定量没有重要意义。超高效液相色谱-串联质谱法测定VLG中的杂质是精确，准确和可靠的，证明对制药行业的分析有效，并提高了开发的新药的质量，安全性和有效性。