羟丙基-磺丁基-β-环糊精包合物冻干粉中多烯紫杉醇的含量及其有关物质测定  

Determination of docetaxel and its related substances in freezing dried hydroxypropyl-sulfur butyl-β-cyclodextrin inclusion complex

作　　者：葛文娜[1] 吴淑燕[1] 刘爱[1] 任勇[2] 余书勤[2] 许茜[1] 

机构地区：[1]东南大学公共卫牛学院,南京210009 [2]南京帅范大学江苏省医药超分子材料及应用重点实验室,南京210076

出　　处：《药物分析杂志》2009年第4期582-586,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立反相高效液相色谱法测定羟丙基-磺丁基-β-环糊精包合物冻干粉中多烯紫杉醇的含量及其有关物质。方法:采用Dikma Platisil C18柱(150mm×4.6mm,5μm),检测波长227nm,柱温:30℃。有关物质检查时以乙腈-水(40∶60,v/v)为流动相A,乙腈为流动相B,进行梯度洗脱,流速1.5mL·min-1;含量测定时紫杉醇为内标,以乙腈-水(60∶40,v/v)为流动相,进行等度洗脱,流速为1.0mL·min-1。结果:多烯紫杉醇与各有关物质分离良好。在0.05～100μg·mL-1的浓度范围内多烯紫杉醇浓度与多烯紫杉醇/紫杉醇峰面积比之间具有良好的线性关系(r=0.9993);重复性好(RSD<1%);平均回收率为100.1%(n=9);检出限为0.01μg·mL-1(S/N=3)。结论:本法准确可靠,专属性强,能满足多烯紫杉醇包合物冻干粉质量控制的要求。Objective：To establish an RP-HPLC method for determination of docetaxel and its related substances in inclusion complex.Method：The separation was performed on a Dikma Platisil C18column（150 mm×4.6 mm,5 μm）.The column was maintained at 30 ℃ and the UV detector was set at 227 nm.Acetonitrile-water（40∶60,v：v）as mobile phase A and acetonitrile as mobile phase B to carry out gradient elution at a flow rate 1.5 mL·min^-1 for the determination of related substances.For the content determination,using acetonitrile-water（60∶40,v：v）as mobile phase to carry out isometric elution at a flow rate 1.0 mL·min^-1,Paclitaxel was used as internal standard.Result：Docetaxel and its related substances could be baseline separated.A linearity between the peak area ratio of docetaxel/internal standard and docetaxel concentration was achieved in the range of 0.05^-100 μg·mL^-1 with r=0.9993.The average recovery was 100.1%（n=9）.The limit of detection was 0.01 μg·mL^-1（S/N=3）.Conclusion：This method is sensitive,accurate and satisfactory in the separable effect,and can be used for quality control of docetaxel inclusion complex.

关 键 词：多烯紫杉醇 羟丙基-磺丁基-β-环糊精 有关物质 含量 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]