摘要
本实验建立了反相HPLC法测定终止早孕新药抗孕唑(DL111-IT)注射液的含量及其相关物质检查的方法。采用ShimpackODS柱,以炔诺酮为内标,甲醇-水7:3(pH7.5)为流动相,检测波长240nm,测得线性范围2~100μg/ml(r=0.9999),平均回收率100.3%,RSD为1.02%。分析了注射液中可能存在的相关杂质及影响因素。最小检出量为14.32pmol。此法简便、专属、准确,可同时进行含量测定与杂质检查。
A reverse phase HPLC method for the determination of DL111-IT injections and its related impurities has been established on the Shimpack ODS C_(18) column with Norethindrone as internal standard and methanol -water(7: 3, pH7. 5) as the mobile phase. Wavelength of the detector was 240nm. The linear correlation was observed from the concentrations of 2μg/ml to 100μg/ml (r=0.9999). The average recovery was 100.3%±1.02%. The detection limit was 14.32 pmol. The method was convenient , selective and accurate. DL111-IT injections and its impurities can be determined simultaneously.
出处
《药物分析杂志》
CAS
CSCD
北大核心
1994年第3期6-9,共4页
Chinese Journal of Pharmaceutical Analysis