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改進HPLC法測定雷替曲塞原料藥中的光學(xué)異構(gòu)體

發(fā)布時間:2018-12-23 11:23
【摘要】:目的:改進高效液相色譜法測定雷替曲塞原料藥中的光學(xué)異構(gòu)體。方法:對色譜柱、流動相和進樣量進行改進,改進后的色譜柱為CHIRALPAK AD-H,流動相為正己烷-無水乙醇-三氟乙酸(70∶30∶0.1,V/V/V),進樣量為100μL,流速為1.0 mL/min,檢測波長為226 nm,柱溫為35℃。結(jié)果:光學(xué)異構(gòu)體檢測進樣量線性范圍為99.68~398.7 ng(r=0.999 9);定量限為4.945 ng,檢測限為1.648 ng;精密度、穩(wěn)定性、重復(fù)性試驗的RSD1.0%;加樣回收率為99.43%~100.14%(RSD=0.25%,n=9)。結(jié)論:改進后的方法簡便、準(zhǔn)確、靈敏度高、重復(fù)性好,可用于測定雷替曲塞原料藥中的光學(xué)異構(gòu)體。
[Abstract]:Objective: to improve the high performance liquid chromatography (HPLC) method for the determination of optical isomers in Reititrexe. Methods: the chromatographic column, mobile phase and injection volume were improved. The improved CHIRALPAK AD-H, mobile phase consisted of n-hexane-anhydrous ethanol-trifluoroacetic acid (70: 30: 0.1 V / V), and the injection amount was 100 渭 L. The flow rate was 1.0 mL/min, and the detection wavelength was 226 nm,. The column temperature was 35 鈩,

本文編號:2389922

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