Determination of Related Substances in Vildagliptin Tablets by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of related substances in Vildagliptin tablets. METHODS:HPLC method was adopted. The determination was performed on Xterra MS C18 column with mobile phase consisted of [phosphate buffer-water-acetonitrie-methanol(400 600 15 15,V/V/V/V)]-[phosphate buffer-acetonitrile-methanol(400 450 150,V/V/V)](gra-dient elution)at the flow rate of 1.2 mL/min. The detection wavelength was set at 210 nm and column temperature was 35 ℃. The sample size was 10 μL. RESULTS:The linear ranges were 18.80-188.0 μg/mL for impurity A(r=0.9995),22.64-226.4 μg/mL for impurity B(r=0.9996),21.74-217.4 μg/mL for impurity C(r=0.9997),19.12-191.2 μg/mL for impurity D(r=0.9998). The limits of detection were 4.18,2.68,1.12,1.34 μg/mL,respectively;RSDs of precision,stability and reproducibility tests were lower than 3%;the recoveries of impurity A,B,C and D were 97.9%-103.1%(RSD=2.01%,n=9),98.8%-104.1%(RSD=1.93%,n=9),98.0%-103.6%(RSD=1.81%,n=9),100.8%-104.1%(RSD=0.98%,n=9),respectively. CONCLU-SIONSThe method is simple and accurate,and can be used for the determination of related substances in Vildagliptin tablets.