本文選題：二對(duì)甲苯磺酸緣生替尼原料藥 + 高效液相色譜法��； 參考：《中國(guó)藥房》2017年03期

【摘要】：目的:建立測(cè)定二對(duì)甲苯磺酸緣生替尼原料藥中有關(guān)物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Waters Symmetry C_(18),流動(dòng)相為甲醇-0.01 mol/L乙酸銨溶液(梯度洗脫),流速為1.0 mL/min,檢測(cè)波長(zhǎng)為240 nm,柱溫為40℃,進(jìn)樣量為10μL。結(jié)果:在該色譜條件下,主成分峰與各雜質(zhì)峰分離度均良好;雜質(zhì)A、B、C和二對(duì)甲苯磺酸緣生替尼檢測(cè)質(zhì)量濃度線性范圍均為0.25~2.0μg/mL(r≥0.999 0),雜質(zhì)A、B、C的定量限分別為0.5、0.5、2.5 ng;精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD1.0%;加樣回收率分別為97.9%~102.6%、95.1%~107.7%、95.8%~107.5%,RSD分別為1.4%、4.2%、4.1%(n=9)。結(jié)論:該方法專屬性好、操作簡(jiǎn)便,可用于二對(duì)甲苯磺酸緣生替尼原料藥中有關(guān)物質(zhì)的測(cè)定。
[Abstract]:Objective: to establish a method for the determination of related substances in BIS. Methods: high performance liquid chromatography was used. The chromatographic column was Waters Symmetry Che _ (18), the mobile phase was methanol-0.01 mol/L ammonium acetate solution (gradient elution, the flow rate was 1.0 mL / min, the detection wavelength was 240 nm, the column temperature was 40 鈩，

本文編號(hào)：1900306