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| Study on the content determination method of Vildagliptin API |
| Wang Lixia 1,2, Wang Yudong 1,2, Wang Peng 1,2, Liu Xinyuan 1,2, Liang Bingchen 1,2 |
| 1. Hebei Hejia Pharmaceutical Technology Group Corporation Ltd., Shijiazhuang 052165, China; 2. Hebei Hejia Pharmaceutical Science and Technology Groupp, Hejia Research Institute, Shijiazhuang 050035, China |
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Abstract A HPLC method was established for the determination of viagliptin. This method uses acetonitrile-0.01m potassium dihydrogen phosphate (adjust the pH to 6.5 ± 0.05 with potassium dihydrogen phosphate solution) (30-70) as the mobile phase, the flow rate is 1.0 mL/min, the temperature is 35 ℃, and the detection wavelength is 210 nm. The results showed that the resolution of the main peak and the main impurities was good, and the blank solvent did not interfere with the determination of the content of viagliptin API; There is a good linear relationship between the mass concentration of vigliptin and the peak area in the range of 0.352-0.601 mg/mL (r=0.999 6). In the repeatability experiment, the RSD value of vigliptin content in the test sample was less than 2%; In the stability test, the RSD value of vigliptin content within 24 h was also less than 2.0%; In the durability test, and under different parameters, the RSD value of vigliptin content is less than 2.0%. This method has strong specificity, high sensitivity, good repeatability and durability. It can be used as a method for determining the content of vildagliptin raw materials, and it can provide a reliable guarantee for the quality and efficacy of the subsequent synthesis of vildagliptin.
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