本文選題：吉非替尼 + 高效液相色譜法��； 參考：《中國藥房》2015年15期

【摘要】：目的:建立測定吉非替尼原料藥含量和有關(guān)物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Sunfire C18,流動相A為醋酸銨溶液、流動相B為乙腈,流速為1.0 ml/min;有關(guān)物質(zhì)測定采用梯度洗脫,進樣量為10μl,檢測波長為240 nm,柱溫為40℃;含量測定采用等度洗脫,進樣量為5μl,檢測波長為247 nm,柱溫為30℃。結(jié)果:有關(guān)物質(zhì)測定方法中各雜質(zhì)及主成分之間能夠很好地分離;吉非替尼及雜質(zhì)A、B、C、D、E和F質(zhì)量濃度分別在0.280 8~28.08(r=0.999 5)、0.042 24~28.16(r=0.999 9)、0.355~28.40(r=0.999 9)、0.283~28.30(r=0.999 9)、0.286 4~28.64(r=0.999 9)、0.098 28~28.08(r=0.999 9)和0.724~28.96μg/ml(r=0.999 9)范圍內(nèi)與各自峰面積呈良好的線性關(guān)系;有關(guān)物質(zhì)和含量測定儀器精密度、中間精密度、穩(wěn)定性試驗的RSD不超過5.97%和0.90%;各雜質(zhì)測定平均回收率在100.6%~106.9%,RSD在0.82%~6.86%(n=9);含量測定平均加樣回收率為100.5%,RSD為0.15%(n=9)。結(jié)論:本方法專屬性強,精密度、準確度和耐用性良好,可用于吉非替尼原料藥的質(zhì)量控制。
[Abstract]:Objective: to establish a method for the determination of gifitinib and its related substances. Methods: high performance liquid chromatography was used. The chromatographic column is Sunfire C18, the mobile phase A is ammonium acetate solution, the mobile phase B is acetonitrile, the flow rate is 1.0 ml / min, the relative substances are determined by gradient elution, the injection amount is 10 渭 l, the detection wavelength is 240 nm and the column temperature is 40 鈩，

本文編號：2116065