高效液相色谱法测定控释地诺前列酮栓含量的方法学考察

Determination of Dinoprostone in Controlled-Release Dinoprostone(PROPESS) by High Performance Liquid Chromatography

目的建立了一种检测控释地诺前列酮栓内地诺前列酮含量的高效液相色谱法。方法采用的色谱柱为Agilent Eclipse XDB-C18柱(4.6mm×150mm,5μm),流动相为0.2%醋酸-乙腈(49:51),流速为0.8mL·min-1,柱温30℃,紫外检测波长为210nm,进样量20μL。结果地诺前列酮保留时间为5.5min,线性范围为24.8～248.0mg·L-1(r=0.9999),最低检出浓度为1.24mg·L-1,回收率为99.3%～100.6%。日内、日间测定的相对标准偏差均小于2.0%。结论该方法简便、快速、稳定、可行,可应用于临床和科研测定控释地诺前列酮阴道栓中地诺前列酮的含量。

OBJECTIVE To establish a method for the determination of dinoprostone by HPLC-UV. METHODS The separation was performed on a Eclipse XDB-Cls column （4.6 mm×150 mm, 5 pm） with 0.2% acetic acid - aethanol （49 ： 51） as the mobile phase,the detection wavelength was 210 nm and the flow rate was 0.8 mL·min-1. The column temperature was 30 ℃ and the amount of injection was 20 μL. RESULTS The retention time of dinoprostone was 5.5 min, the linear range of the method was from 24.8 to 248.0 mg·L1, and the detection limit was 1.24 mg·L-1. The recoveries of dinoprostone were from 99.3 %-100.6%, the intraday and interday variations were less than 2.0%. CONCLUSION The method is simple, accurate, and suitable for routine analysis.