HPLC测定奥硝唑注射液中的有关物质

Determination of related substances in Ornidazole injection by HPLC

目的采用HPLC法测定奥硝唑注射液中的有关物质。方法采用Topsil C18色谱柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(22∶78),流速1.0 mL·min-1,波长318 nm处采用不加校正因子的主成分自身对照法对有关物质进行检查。结果0.1～100μg·mL-1奥硝唑与峰面积的线性关系良好(r=0.9999),检测限为1 ng(S/N=3),单一最大杂质的检查限度为0.5%,有关物质总量的检查限度为1.0%。结论所用方法专属性强、准确、简便、快速,适用于奥硝唑注射液中有关物质的检查。

OBJECTIVE To establish an HPLC method for determination of the related substances in Ornidazole injection.METHODS The analytical column was Topsil C18 column（150 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-water（22：78）.The flow rate was 1.0 mL·min-1 and the detective wavelength was 318 nm.RESULTS The calibration curve was linear within the range of 0.1-100 μg·mL-1 for Ornidazole（r=0.9999） and the limit of detection was 1 ng（S/N=3）.The limit of the largest impurity was 0.5% and the limit of the related subsances was 1.0%.CONCLUSION The method is specific,accurate,simple,sensitive,and suitable for determination of related substances in Ornidazole injection.