HPLC法测定硫酸黏菌素组分含量

Determination of Constituents Contents of Colistin Sulfate by HPLC Method

目的:采用HPLC法测定硫酸黏菌素组分含量。方法:测定色谱条件为:色谱柱为C18,5μm,4.6mm×250mm,流动相为:称取无水硫酸钠13.38g用纯化水稀释至2700m L,用稀磷酸调节p H至2.3~2.5,加水稀释至3000m L,再加乙腈846m L,摇匀,过滤,即得。检测波长为215nm。结论:硫酸黏菌素在0.2~0.6mg/m L范围内线性关系良好,多黏菌素E1:相关系数R=0.9995、多黏菌素E2:相关系数R=0.9998、多黏菌素E3:相关系数R=0.9999、多黏菌素EI-1:相关系数R=0.9992、多黏菌素EI-7MOA:相关系数R=0.9996;硫酸黏菌素的回收率为98.6%~101.6%;多黏菌素E1重复性RSD为0.2%、多黏菌素E2重复性RSD为0.2%、多黏菌素E3重复性RSD为0.8%、多黏菌素EI-1重复性RSD为0.6%、多黏菌素EI-7MOA重复性RSD为0.5%。结论:该方法线性范围宽、分析时间短、样品前处理简便、定量结果准确、重现性好,为其质量控制提供了依据。

Objective：To determine the colistin sulfate content by using the HPLC method.Methods：Determination ofchromatographic condition：chromatographic column for C18,5μm,4.6mm×250mm,mobile phase：to get anhydroussodium sulfate 13.38 g diluted with purified water to 2700 m L,adjusted the p H to 2.3~2.5 with dilute phosphoric ac-id,diluted with water to 3000 m L,and then add acetonitrile 846 m L,shake,filtering,is obtained.The detection wave-length was 215 nm. Conclusion：colistin sulfate in 0.2~0.6mg/m L is in good linear relationship,and polymyxin E1：correlation coefficient R = 0.9995,polymyxin E2,correlation coefficient R=0.9998,polymyxin E3,correlation coeffi-cient R=0.9999,polymyxin EI-1：the coefficient of R=0.9992,polymyxin EI-7MOA：correlation coefficient R=0.9996;colistin sulfate recovery rate is 98.6%~101.6%;polymyxin E1 RSD of repeatability was 0.2%,polymyxinE2 RSD of repeatability was 0.2%,polymyxin E3 RSD of repeatability was 0.8%,polymyxin E I-1 RSD of repeatabil-ity was 0.6%,polymyxin EI-7MOA repetitive RSD 0.5%.conclusion：it provides a basis for its quality control as itswide linear range,short analysis time,sample pretreatment is simple,accurate and reproducible.