HPLC法测定头孢噻肟钠乙酸含量

Determination of Acetic Acid in Cefotaxime Sodium by HPLC

目的:建立高效液相色谱法测定头孢噻肟钠原料乙酸含量。方法:采用Zorbox Edipse XDB C18(4.6 mm×150 mm,5μm)色谱柱,以0.1%磷酸水溶液-甲醇(99∶1)为流动相,流速0.8 mL·min^-1,柱温30℃,检测波长210 nm。结果:乙酸在0.02mg·mL^-1~0.20mg·mL^-1范围内线性关系良好(r^2>0.999)。6批头孢噻肟钠样品测定结果显示,乙酸含量小于0.5%。结论:经方法学验证,本法灵敏度高,专属性好,可用于头孢噻肟钠乙酸杂质的质量控制。

Objective:To establish HPLC method for the determination of acetic acid in cefotaxime sodium.Methods:HPLC was adopted on a Zorbox Edipse XDB C18 column(4.6 mm×150 mm,5μm)with a isocratic elution system of 1% phosphoric acid solution-methanol(99∶ 1).The flow rate was 0.8 mL·min ^-1 ,and the column temperature was maintained at 30℃,the detection wavelength was set at 210 nm.Results:It had a good linearity in the concentration range of 0.02mg·mL^-1 ~0.20mg·mL ^-1 (r^ 2 >0.999).The determination results of the six batches of cefotaxime sodium samples showed that the acetic acid was less than 0.5%.Conclusion:The method is proved that it has good sensitivity and specificity,and it is suitable for the quality control of acetic acid in cefotaxime sodium.