摘要
目的建立高效液相色谱法测定注射用硫酸头孢匹罗的含量。方法采用ODS2色谱柱（5μm，4．6mm×200mm），乙腈-pH3．6磷酸盐缓冲液（称取枸橼酸1．42g、磷酸氢二钠4．36g加水溶解并稀释至1000mL）（12：88）为流动相，流速1．0mL·min^-1，检测波长265nm，外标法计算含量。结果硫酸头孢匹罗在12．5μg·mL^-1～125μg·mL^-1的浓度范围内，线性关系良好，回归方程A=48．00C＋26．15，r=0．9999；系统精密度RSD为0．098％（n=6）。结论本方法操作简便、快捷，方法的精密度、准确度均能很好地满足质量控制的要求。适合于注射用硫酸头孢匹罗的含量测定。
OBJECTIVE To establish a HPLC method for the determination of the content of cefpirome sulfate for injection. METHODS The HPLC system consisted of ODS2 column（5μm, 4.6mm×200mm）, acetonitrile- PBS buffer （pH3.6） （12 ： 88） as mobile phase with the flow rate of 1.0mL· min^- 1, and UV detector wavelength was 265nm, calculated with the external method . RESULTS Under the condition, there was a good linear relationship in the concentration range of 12.5μg· mL^- 1 - 125μg. mL^- 1 （A = 48.00C ＋ 26.15. r = 0. 99998）, the system precision（RSD = 0.098 %, n = 6） was good. CONCLUSIONS This method is simple, rapid, precise, and accurate, providing an effective way in quality control, and is suitable for the determination of the content of cefpirome sulfate for injection.
出处
《海峡药学》
2008年第11期29-31,共3页
Strait Pharmaceutical Journal
