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改进测定奥硝唑氯化钠注射液中有关物质的HPLC分析方法。采用C18色谱柱,以甲醇∶水(20∶80)为流动相,检测波长318 nm。奥硝唑与杂质2-甲基-5-硝基咪唑(2)及2-甲基-5-硝基-1-(2,3-二羟基丙基)咪唑(3)在0.2~2.0μg/ml范围内线性关系良好。2和3的平均回收率为100.1%和97.9%,RSD为0.9%和1.5%。2、3的紫外吸收与奥硝唑的校正因子为0.75和1.73。
Improved HPLC method for the determination of related substances in ornidazole and sodium chloride injection. C18 column was used with methanol: water (20:80) as the mobile phase and the detection wavelength was 318 nm. Ornidazole and impurities 2-methyl-5-nitroimidazole (2) and 2-methyl-5-nitro-1- (2,3-dihydroxypropyl) imidazole (3) / ml within a good linear relationship. The average recoveries of 2 and 3 were 100.1% and 97.9% with RSDs of 0.9% and 1.5%. 2,3 UV absorbance and ornidazole correction factor 0.75 and 1.73.