盐酸托泊替康质量分析方法研究

Methods for the Quality Control of Topotecan Hydrochloride

对盐酸托泊替康的有关物质、含量测定两个项目进行研究。采用HPLC，使用C18柱，流动相为体积分数0．59／6三乙胺溶液和质量分数0．0432％的十二烷基硫酸钠（用磷酸调节PH4．0）-甲醇（50：50），波长267nm。结果显示，本品在0．008～0．072mg／mL范围内线性关系良好，回归方程为A=272671ρ-1653．2（r=0．999，n=5），平均回收率不低于99．2％，与降解产物和中间品有较好的分离，溶液8h内稳定，故可知所建立的分析方法专属性强、灵敏度高，测定结果准确可靠，适用于盐酸托泊替康的质量控制。

Related substance and contents of topotecan hydrochloride were studied. The separa- tion was performed in the C18 column, and the mobile phase consisted of 0.5% triethylamine and 0. 043 2% sodium dodecyl sulfate （adjusted the solution with phosphoric acid to pH 4.0 ）-methanol （50：50）with the detection wavelength of 267 nm. The calibration curves were linear in the ranges of 0. 008-0. 072 mg/mL, and the average recoveries were not less than 99.2%0. Topotecan hydrochloride and related substances could be separated well. Samples were stable in 8hrs. The methods were proved to be accurate and reliable with high selectivity, sensitivity and repro-ducibility, and were suitable for the quality control of topotecan hydrochloride.