摘要
目的:建立测定硫酸西索米星有关物质检查的HPLC-ELSD法。方法:采用CAPCELL PAK TYPE:ACR C18(250 mm×4.6 mm,5μm)色谱柱,流动相为0.3 mol/L三氟乙酸-甲醇-乙腈(96∶3∶1),流速为0.5 ml/min,柱温:40℃;检测器为Alltech ELSD 2000 ES蒸发光散射检测器(仪器参数:漂移管温度110℃,气体流速3.0 L/min,Gain=1,Impactor=off)。结果:在选定色谱条件下,西索米星和有关物质分离良好。硫酸西索米星在0.15～2.38μg范围内线性关系良好,线性方程为Y=1.725 0 X+5.954 2(r=0.999 8)。结论:方法快速、简便,结果准确可靠,重现性好,可用于硫酸西索米星有关物质检测。
Objective ： To establish an HPLC - ELSD method for determination of related substances in sisomicin sulfate. Methods： The separation was performed on a CAPCELL PAK TYPE：ACRC18（250mm×4.6mm,5μm） at 40 ℃. The mobile phase consisted of 0.3 mol/L tritluoroacetic acid - acetonitrile - Methanol196： 3： 1 }. The flow rate was 0.5 mL/min. An AUtech ELSD 2000ES detector of drift tube temperature at 110 ℃was used and the gas flow was 3.0 L/min. The value of the Gain was 1 and the Impactor was turned off. Results ： Good separations of sisomicin and main related substances were achieved In the range of 0.15 - 2.38μg,the linear was perfect. Conclusion： The method is rapid and simple, the result are accurate and reproducible. The method can be used to determination of related substances in sisomicin sulfate.
出处
《天津药学》
2011年第6期8-11,共4页
Tianjin Pharmacy
