HPLC法测定注射用硫酸头孢噻利的含量

Content Determination of Cefoselis Sulfate for Injection by HPLC

目的:建立测定注射用硫酸头孢噻利含量的方法。方法:采用高效液相色谱法。色谱柱为Ultimate C18,流动相为甲醇-水(20∶80),柱温为30℃,流速为1mL·min-1,检测波长为257nm,进样量为20μL。结果:硫酸头孢噻利检测浓度线性范围为10.0～120.0μg·mL-1(r=0.9999);最低检测限为0.01μg·mL-1;低、中、高3种浓度硫酸头孢噻利的方法回收率分别为101.9%、100.3%、99.5%,日内RSD分别为1.07%、1.38%、1.40%,日间RSD分别为1.07%、2.58%、2.87%;3批样品平均标示含量为(96.5±1.7)%。结论:该方法简便、灵敏度高,适用于注射用硫酸头孢噻利的含量测定。

OBJECTIVE： To establish a method for the content determination of Cefoselis sulfate for injection. METHODS： HPLC method was adopted. The separation was performed on Ultimate Ct8 column and the column temperature was 30 ℃. The mobile phase consisted of methanol-water （20：80） with a flow rate at 1 mL.min^-1. The detection wavelength was set at 257 nm and injection volume was 20 μL. RESULTS： The linear range of cefoselis sulfate was 10.0~120.0 μg·mL^-1（r=0.999 9）. The detection limit was 0.01 μg·mL^-1. The method recoveries were 101.9%, 100.3% and 99.5% at low, medium, high concentrations. The intra-day RSD were 1.07%, 1.38% and 1.40%, and inter-day RSD were 1.07%, 2.58% and 2.87%, respectively. The average content of 3 batches of Cefoselis sulfate for injection was （96.5 ± 1.7）%. CONCLUSION： The method is simple and sensitive for the content determination of Cefoselis sulfate for injection.