RP-HPLC法测定自乳化释药系统中伊曲康唑的含量  

RP-HPLC determination of itraconazole in self-emulsifying drug delivery system

作　　者：宋笑丹[1] 唐景玲[2] 邸哲婷[3] 魏华[3] 吴琳华[3] 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,哈尔滨150001 [2]哈尔滨医科大学药学院,哈尔滨150081 [3]哈尔滨医科大学附属第二医院药学部,黑龙江省高校重点实验室,哈尔滨150086

出　　处：《药物分析杂志》2009年第7期1070-1072,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立自乳化释药系统中伊曲康唑含量测定的RP-HPLC法。方法:采用Diamonsil C18(4.6mm×200mm,5μm)色谱柱,流动相为甲醇-水(90∶10),流速1.0mL·min-1,检测波长261nm,柱温25℃,进样量20μL。结果:在本色谱条件下伊曲康唑与辅料及溶剂峰分离良好,伊曲康唑在1.0～50.0μg·mL-1质量浓度范围内与峰面积呈良好的线性关系(r=0.9999),精密度试验的RSD为0.7%～3.2%(n=5),重复性试验的RSD为2.9%(n=5),平均回收率为101.9%(n=5)。结论:该方法简便、易行,可用于自乳化释药系统中伊曲康唑的含量测定。Objective ： To establish an RP - HPLC method for determining the content of itraconazole in self - emulsifying drug delivery system. Methods：HPLC analysis was performed on a Diamonsil C18 column（4.6 mm× 200 mm,5 μm）with mobile phase of methanol- water（90： 10）. The flow rate was 1.0 mL · min^-1. The UV detector wavelength was set at 261 nm . The column compartment temperature was set at 25 ℃. The injection volume was 20 μL. Results ： Itraconazole had a good linear relation in the range of 1.0 - 50. 0 μg · mL^-1 （ r = 0. 9999）. The precision （RSD） was 0.7% - 3.2% （ n = 5 ）, the reproducibility（RSD） was 2. 9% （ n = 5 ）, the average recovery rate was 101.9% （n = 5）. Conclusion：The developed method is simple,accurate and reliable for determination of the content of itraconazole in self - emulsifying drug delivery system.

关 键 词：伊曲康唑 自乳化 RP-HPLC 含量测定 

分 类 号：R917[医药卫生—药物分析学]