本文選題：恩格列凈 + 有關(guān)物質(zhì)��； 參考：《南京醫(yī)科大學(xué)學(xué)報(自然科學(xué)版)》2017年01期

【摘要】：目的:建立恩格列凈原料藥純度及所含雜質(zhì)的測定方法。方法:采用高效液相色譜(HPLC)法,用Waters symmetry C18色譜柱(250 mm×4.6 mm,5μm),以0.01%(V/V)三氟乙酸溶液為流動相A,乙腈為流動相B,線性梯度洗脫:0~10 min,流動相B 32%;10~50 min,流動相B 32%~95%;檢測波長225 nm,流速1.0 m L/min,柱溫45℃。結(jié)果:恩格列凈與各雜質(zhì)的分離度均1.5,檢出限均9 ng/m L,線性范圍滿足定量分析要求;重復(fù)性試驗(yàn)相對標(biāo)準(zhǔn)差(RSD)均5%;供試品溶液和對照溶液在8 h內(nèi)穩(wěn)定性良好;各雜質(zhì)的回收率為88.6%~106.1%,RSD均10%。結(jié)論:本研究建立的方法檢測靈敏度高,精密度好,可作為恩格列凈原料藥有關(guān)物質(zhì)的控制方法。
[Abstract]:Objective: to establish a method for the determination of purity and impurity in Englicine raw material. Methods: high performance liquid chromatography (HPLC) was used. Waters symmetry C18 column was used as the mobile phase A, acetonitrile as the mobile phase, the mobile phase as a mobile phase, acetonitrile as the mobile phase, the mobile phase as a gradient elution for 10 minutes, the mobile phase as the mobile phase for 10 ~ 1050 minutes, the mobile phase as the mobile phase, the detection wavelength was 225 nm, the flow rate was 1.0 mL / min, and the column temperature was 45 鈩，

本文編號：2036103