摘要
目的:建立优化HPLC法测定注射用头孢呋辛钠含量的方法,以醋酸盐缓冲液(取醋酸钠0.68 g,冰醋酸5.8 g,加水稀释成1000 mL,用冰醋酸调节pH值至3.4)为流动相A,以乙腈为流动相B,梯度洗脱。流速:1.0 mL/min,柱温:30℃,检测波长:273 nm;进样体积:20 u。结果:头孢呋辛在0.025~0.5 mg/mL浓度范围之间线性良好,R=1.0000;平均回收率为:99.8%;RSD=0.3%(n=6)。结论:头孢呋辛主峰与杂质峰的分离度达到3.0以上,结果准确稳定,同时适合不同品牌的C8色谱柱,可用于头孢呋辛钠的含量测定。
Objective to establish an optimized HPLC method for the determination of cefuroxime sodium for injection.Acetate buffer(0.68 g sodium acetate,5.8 g glacial acetic acid,diluted to 1000ml with water,adjusted the pH value to 3.4 with glacial acetic acid)was used as mobile phase a,acetonitrile as mobile phase B,gradient elution.Flow rate:1.0 mL/min,column temperature:30℃,detection wavelength:273 nm;Injection volume:20 uL.Results:cefuroxime had good linearity in the concentration range of 0.025~0.5 mg/mL,r=1.0000;The average recovery was 99.8%;RSD=0.3%(n=6).Conclusion:the resolution between the main peak and impurity peak of cefuroxime is more than 3.0.The results are accurate and stable.At the same time,it is suitable for C8 chromatographic columns of different brands and can be used for the determination of cefuroxime sodium.
作者
谭彩花
黄婉锋
徐苹
郭智聪
Tan Caihua;Huang Wanfeng;Xu Ping;Guo Zhicong(Foshan Institute for Food and Drug Control,Foshan 528000,China)
出处
《广东化工》
CAS
2023年第15期150-153,共4页
Guangdong Chemical Industry
