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《China Medicine and Pharmacy》 2017-15
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Study on the determination of related substances in vildagliptin

HUANG Yan;YANG Xuefeng;CHEN Xueyun;FU Naiguang;CHEN Nian'gen;ZHONG Xia;School of Pharmacy,Hainan Medical University;Haikou Nanlu Pharmaceutical Technology Co.,Ltd;  
Objective To establish an HPLC method to determine the related substance in Vildagliptin. Methods The column was Waters XTerra MS C_(18)(4.6mm×50mm,3.5μm),the mobile phase A was treated with phosphate bufferwater-acetonitrile-methanol(80:120:3:3),the mobile phase B was treated with phosphate buffer-water-acetonitrilemethanol(8:9:3),which was used as gradient elution.The detection wavelength was 210 nm,the flow rate was 1.5m L/min. Results The resolution of vildagliptin and its related substance was above 1.3,detection limit was 1.2 ~ 1.6ng, quantification limit was 2.4 ~ 3.3ng. Conclusion The method was suitable for the determination of related substance in vildagliptin.
【Fund】: 海南省产学研一体化专项项目(CXY20140011)
【CateGory Index】: O657.72;R927.2
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