奥硝唑氯化钠注射液中有关物质的HPLC法测定

Determination of Related Substances in Ornidazole and Sodium Chloride Injection

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0.2～2.0 μg/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.

The HPLC method was improved for the determination of the related substances in ornidazole and sodium chloride injection.A C18 column was used,with the mobile phase of methanol ∶ water （20 ∶ 80）,at the detection wavelength of 318 nm.The calibration curves for ornidazole,2-methyl-5-nitroimidazole （2） and 2-methyl-5-nitro-1-（2,3-dihydroxypropyl） imidazole were linear in the concentration range of 0.2-2.0 μg/ml.The average recoveries of 2 and 3 were 1 00.1％ and 97.9 ％,with RSDs of 0.9 ％ and 1.5 ％,respectively.The corrective factors of UV absorption for 2 and 3 were 0.75 and 1.73,compared with ornidazole.