HPLC法测定亚胺培南的有关物质

目的：建立亚胺培南有关物质的测定方法。方法：采用Hypersil ODS 250mm 4．6mm（5μm）色谱柱，A相（0.01mol／L磷酸二氢钾溶液）-B相（甲醇）为流动相，梯度洗脱，检测波长300nm，柱温为室温。结果：亚胺培南自身对照溶液在供试品溶液0．2％～1．2％浓度范围内呈线性，硫霉素峰和亚胺培南峰的分离度大于4．0。结论：该方法灵敏度高、专属性强、结果准确可靠，可用于亚胺培南有关物质的检查。

Determination of related substance in imipenem by HPLC

Objective：To establish a method for determining related substance in imipenem. Methods：The HPLC method was used a Hypersil ODS 250 mm 4.6 mm （5 μm） column,the mobile phase was consisted of solvent A-0.01 mol/L Potassium Dihydrogen Phosphate and solvent B- Methanol with gradient elution program. The detective wavelength was 300 nm and the column temperature was room temperature. Results：The calibration curves of imipenem was in good linearite over the range of 0.2%-1.2% testing solution concentration. The resolution between the imipenem and thienamycin peaks was not less than 4.0. Conclusion：This method is sensitive, specific, accurate and reliable, it is suitable to the determination of re- lated substance in imipenem.