HPLC法测定奥硝唑注射液中2-甲基-5-硝基咪唑的含量

Determination of 2-Methyl-5-nitroimidazole in Ornidazole Injections by HPLC

目的:建立定量检测奥硝唑注射液中杂质2-甲基-5硝基咪唑的HPLC方法。方法:采用WatersC18(250 mm×4.6 mm,5μm)色谱柱,以甲醇-水-冰醋酸(20∶80∶0.2)为流动相,流速1.0 ml.min-1,柱温25℃,检测波长318 nm,进样量20μl。结果:2-甲基-5-硝基咪唑在0.10～6.22μg.ml-1内线性关系良好(r=0.999 9),平均回收率为100.42%,RSD=1.61%(n=9)。结论:该方法准确可靠,专属性强,可用于奥硝唑注射液中2-甲基-5-硝基咪唑的定量检测。

Objective： To develop an HPLC method for the determination of 2-methyl-5-nitroimidazole in onidazole injections.Method： The experiments were performed on a Waters C18 column（250 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-water-acetic acid（20∶ 80∶ 0.2 v/v） at a flow rate of 1.0 ml·min-1.The detection wavelength was set at 318 nm.The column temperature was 25℃ and the injection volume was 20 μl.Result： The linear range was 0.10~6.22 μg·ml-1（r=0.999 9） for 2-methyl-5-nitroimidazole and the average recovery was 100.42%（RSD=1.61%,n=9）.Conclusion： The method is precise,accurate,specific and sensitive,and can be used in the quantitative detection of 2-methyl-5-nitroimidazole in ornidazole injections.