高效液相色谱法测定青霉素盐的有关物质

目的建立青霉素钠（钾）中有关物质检查的高效液相色谱（HPLC）法。方法采用C18柱，以磷酸盐缓冲液（0．1mol／L磷酸二氢钾溶液用磷酸调pH至2．5）-乙腈（80：20）为流动相A，以磷酸盐缓冲液（0．1mol／L磷酸二氢钾溶液用磷酸调pH至2．5）-乙腈（75：25）为流动相B，采用线性梯度洗脱，流速1．0mg／mL，检测波长225nm。结果在所建立的色谱条件下，各色谱峰峰形正常，保留时间适中，主成分峰与各杂质峰分离良好。结论所建立的HPLC法简便、准确、灵敏，可同时对产品中的有关物质进行准确监控。

Determination of Benzylpenicillin Sodium(Potassium) Related Substances by HPLC

Objective To establish a method for determination of benzylpenicillin sodium（potassium） related substances by HPLC. Methods The C18 column was used. The mobile phase A was phosphate buffer （0. 1 mol/L potassium dihydrogen phosphate solution, pH adjusted to 2.5 by phosphoric acid）： acetonitrile （80：20）. The mobile phase B was phosphate buffer （0. 1 mol/L potassium dihydrogen phosphate solution, pH adjusted to 2.5 by phosphoric acid ）： acetonitrile （75：25）. The linear gradient elution was adopted with the flow rate of 1.0 mg/mL. The wavelength of UV detector was 225 nm. Results Under the established chromatographic conditions, the peak shape was symmetrical, resolution was good and retention time was moderate. Conclusion The method is convenient, accurate and sensitive, which can accurately monitor and control the related substances in products.