青霉素V钾片含量测定中流动相影响因素的探讨

Exploration on the influencing factors of mobile phase in the content determination of Penicillin V Potassium Tablets

目的:改进青霉素V钾片含量的测定方法。方法:采用Dikma C18(4.6mm×200mm,5μm),Shiseido MG(4.6mm×200mm,5μm),Waters C18(4.6mm×200mm,5μm)色谱柱;流动相:乙腈-0.1mol/L磷酸二氢钾溶液-三乙胺(40∶60∶0.1),用冰醋酸调pH至4.0;检测波长:268nm;流速1.0ml/min;柱温:26℃。结果:青霉素V钾在1.12～36.05μg范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率99.70%,RSD=0.32%(n=6)。结论:本方法简便、准确、重现性好,可用于青霉素V钾片中青霉素V的质量控制。

Objective：To improve the method for the content determination of Penicillin V in Penicillin V Potassium Tablets.Methods：The Dikma C18（4.6 mm×200 mm,5 μm）column,Shiseido MG（4.6 mm×200 mm,5 μm）column,Waters C18（4.6 mm×200 mm,5 μm）column were used.The mobile phases consisted of acetonitrile,potassium dihydrogen phosphate solution-0.1 mol/L and triethylamine（40：60：0.1）,with pH was adjusted to 4.0 by acetic acid.The flow rate was 1.0 ml/min and the detection wavelength was at 268 nm.The column temperature was 26℃.Results：The linear ranges of Penicillin V Potassium was at 1.12-36.05 μg（r=0.999 9）,the average recovery was 99.70% with a RSD of 0.32%（n=6）.Conclusion：The method is fast,reliable,accurate and can be used in the quality control of Penicillin V in Penicillin V Potassium Tablets.