HPLC法测定萘夫西林钠原料及注射用无菌粉末中主药及有关物质的含量

目的:建立萘夫西林钠原料药及其注射用无菌粉末中主药及有关物质含量测定的HPLC法。方法:色谱柱采用C18,以0.05mo·lL-1醋酸钠溶液(pH=7.5)-乙腈(75∶25)为流动相,检测波长为230nm。结果:萘夫西林与相邻杂质峰分离完全,萘夫西林检测浓度线性范围为0.04～1.14mg·mL-1(r=0.9999);平均回收率为99.5%(RSD=0.60%,n=9),检测限为2ng;所检测样品中有关物质含量均小于0.34%。结论:该方法专属性强、精密度好、灵敏度高,可用于萘夫西林钠及其注射用无菌粉末的质量控制。

Content Determination of Main Component and Related Substances in Nafcillin Sodium Raw Material and Its Sterillized Powder for Injection by HPLC

OBJECTIVE： To establish an HPLC method for the determination of main component and related substances in nafcillin sodium and its sterillized powder for injection. METHODS： HPLC analysis was performed on a C18 column with 0.05 mol·L-1 sodium acetate solution （pH=7.5）-acetonitrile （75 ∶ 25） as mobile phase. The detection wavelength was 230 nm. RESULTS： Nafcillin could be separated from the adjacent impurities completely. The linear range of nafcillin was 0.04～1.14 mg·mL-1 （r=0.999 9） with an average recovery of 99.5% （RSD=0.60%, n=9）. The detection limit of nafcillin was 2 ng. The contents of related substance were all lower than 0.34%. CONCLUSION： The method is specific, precise and sensitive for the quality control of nafcillin sodium raw material and its sterillied powder for injection.