HPLC法测定头孢克洛原料中杂质C的研究

HPLC method for determination of cefaclor impurity C

目的 建立头孢克洛原料中杂质C（D-头孢克洛）的HPLC测定方法。方法 采用C18（4．6mm250mm，5μm）色谱柱；流动相为0．78％磷酸二氢钠溶液（取磷酸二氢钠7．8g，加水溶解并稀释至1000mL，用磷酸调pH值至4．0）．乙腈（90：10）；流速1．0mL／mim检测波长254nm：柱温35℃。结果 杂质C在1．22～2．85μg范围内线性关系良好（严0．9995，n=5），平均回收率为99．89％，RSD为0．59％0=9），定量限为2．038ng。结论该方法简便、准确、重现性好，可用于头孢克洛原料中杂质C的检测。

Objective To establish an HPLC method for content determination of cefaclor impurity C（D-cefaclor） in cefaclor was establish. Methods The determination was performed on HPLC, C18 （4.6mmx250mm,5gm） column with mobile phase consisted of 0.78% sodium dihydrogen phosphate solution （taking sodiumdihydrogen phosphate 7.8g, dissolved in water and diluted to 1000mL, pH adjusted to 4.0 with phosphoric acid）-acetonitrile（9010）, and flow was 1.0mL/min, detection wavelength was 254nm, and column temperature was 35℃.Results The method showed a good liner relationship within the range of 1.22-2.85μg of impurity C （r=0.9995,n=5）, the average recovery was 99.89% with RSD=0.59% （n=9）, and the limit of quantification was 2.038ng.Conclusion The method is simple, accurate and have good reproducibility, and it could be used to contentdetermination of cefaclor impurity C in cefaclor.