HPLC法测定注射用头孢匹胺钠的含量和有关物质

Determination of related substances and content of Cefpiramide Sodium for Injection by HPLC

目的建立高效液相色谱法测定注射用头孢匹胺钠中头孢匹胺的含量和有关物质含量。方法色谱柱为C8（5μm，250×4．6mm），磷酸盐缓冲液-甲醇（75：25）为流动相，检测波长254nm，流速为1．0ml·min^-1。结果本方法中头孢匹胺的回收率为100．0±2．0％，相对标准偏差小于3％，最小检测限为250ng，头孢匹胺钠溶液在0．4099～0．6149mg·ml^-1的浓度范围内，含量测定线性回归方程为：A=7351270．8 C-4136．7，r=0．9990。本品在强制条件下的降解产物与主峰能的分离度均大于1．5。结论本方法可有效地控制注射用头孢匹胺钠质量。

OBJECTIVE A method based on high performance liquid chromatography （HPLC） with UV detection system was developed and validated aiming at the determination of related substance and content cefpiramide sodium for injection. METHODS The proposed method includes C8 （5μm, 250×4.6mm）column, the mobile phase was phosphate salt buffer solution-methanol（75 ： 25）, the detection wavelength was set at 254nm and flow rate was 1.0ml·min^-1. RESULTS The mean recovery of cefpiramide was 100.0±2.0% with RSD values less than 3%. The limit of determination, based on a signal-to-noise ratio of 3 ： 1, was 250ng. The reveals linearity equation was in concentration range 0.4099～0.6149mg·ml^-1, A = 7351270.8 C - 4136.7, r = 0.9990. The cefpiramide could be separated effectively from its degradation product with the method. Degree of separation was more than 1.5. CONCLUSION The proposed method was a useful alternative for routine analysis in the quality control of medicine.