抗孕唑注射液及其相关物质的反相高效液相色谱分析法  

HPLC Determination of DL111-IT Injections and Its Related Impurities

作　　者：姚彤炜[1] 汪作良[1] 

机构地区：[1]浙江医科大学药学系

出　　处：《药物分析杂志》1994年第3期6-9,共4页Chinese Journal of Pharmaceutical Analysis

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.

关 键 词：抗孕唑 高效液相色谱 杂质检查 

分 类 号：R927.2[医药卫生—药学]