那格列奈中L-异构体和顺式异构体的HPLC法测定

HPLC determination of L-isomer and cis-isomer in nateglinide and its tablets

目的:建立 HPLC 法同时测定那格列奈中的杂质 L-异构体和顺式异构体的含量。方法:用 Chirobiotic R 手性色谱柱,甲醇-乙腈(1:1,加0.2%的醋酸和0.1%的三乙胺)为流动相,流速0.6 mL·min^(-1),检测波长210 nm。结果:同时分离测定了那格列奈中 L-异构体和顺式异构体,定量限为2 ng,检测限为0.6 ng,L-异构体的回收率为100.5%,顺式异构体回收率为98.7%。结论:方法快速简便,准确,能同时有效分离和测定那格列奈中 L-异构体和顺式异构体。

Objective： To establish an HPLC method for determination of L - isomer and c/s - isomer as impurities in nateglinide and its tablets. Method： A Chirobiotic R column was used with methanol - acetonitrile （ 1： 1 ） containing 0. 2% acetic acid and 0. 1% triethylarnine as mobile phase. The flow rate was 0. 6 mL · min^-1. The detection wavelength was 210 nm. Results： The L- isomer and c/s -isomer in nateglinide and its tablets could be separated The limits of detection and quantitation of nateglinide were 0. 6 ng and 2 ng, respectively. The recoveries of L - isomer and c/s -isomer were 100. 5% and 98.7% ,respectively. Conclusion.This method is rapid, simple and can be used for the resolution and determination of the L - isomer and c/s - isomer in nateglinide and its tablets.