高效液相色谱法测定氟维司群微球的含量和体外释放度  

Quantitative and release analysis of fulvestrant microsphere by HPLC

作　　者：王九成[1] 梁国正[1] 

机构地区：[1]西北工业大学理学院应用化学系,陕西西安710072

出　　处：《中国生化药物杂志》2009年第5期333-335,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的建立氟维司群微球的含量和体外释放度测定方法。方法采用Kromasil C8（250mm×4．6mm，5μm）色谱柱，甲醇-乙腈-水（70：7．5：22．5）为流动相，检测波长为285nm。结果氟维司群浓度在1．0～20．0μg／mL和30．0～50．0μg／mL范围内线性关系良好，R^2值均为0．9998。精密度试验RSD为0．6％（n=6），回收率为100．83％，RSD为0．55％（n=9）。Purpose To develop a sensitive and specific HPLC method for the quantitative and released sample in vitro analysis of fulvestrant mierosphere. Methods The chromatographic analysis was performed on a Kromasil C8 column （250 mm×4.6 mm, 5 μm）, using mobile phase （70 % methanol - 7.5 % acetonitrile- 22.5 % water） at a flow rate of 1.2 mL/min. The eluent was monitored at the wavelength of 285 nm. Results Calibration curves were linear over the concentration range of 1.0-20.0μg/mL and 30.0-50.0 μg/mL, R2 value was all 0.999 8. The accuracy RSD was 0.6% （n = 6）. The recoveries were 100.83% （n = 6） with the RSD 0.55 % . Conclusion The sensitive, specific and reliable method is suitable for the quantitative of fulvestrant mierosphere, and also suitable for the measurment of released sample in vitro.

关 键 词：氟维司群 微球 高效液相色谱法 含量测定 体外释放度 

分 类 号：R927.1[医药卫生—药学]