高效液相色谱法测定注射用卡络磺纳中卡络磺纳的含量

Determination of Carbazochrome Sodium Sulfonate in Carbazochrome Sodium Sulfonate for Injection by HPLC

目的:建立以高效液相色谱法测定注射用卡络磺钠含量的方法。方法:色谱柱为C18,流动相为0.12%磷酸二氢铵缓冲液-无水乙醇(925∶75),流速为0.8ml/min,检测波长为363nm,进样量为10μl,柱温为25℃。结果:卡络磺钠检测浓度在0.08865～0.4432mg/ml范围内线性关系良好(r=0.9999,n=5),平均回收率为99.89%(RSD=1.53%,n=9)。结论:本方法简便、快捷、准确、精密度高,可用于注射用卡络磺钠的质量控制。

OBJECTIVE：To establish a method for determination of carbazochrome sodium sulfonate for injection .METHODS： C18 was used as chromatographic column; the mobile phase consisted of 0.12% ammonium dihydrogen phosphate buffer solution-absolute alcohol（925 ： 75） with detection wavelength at 363nm and flow rate at 0.8ml/min.The sample size was 10μl and the column temperature was 25℃ . RESULTS：Linear relation was achieved when the concentration of carbzochrome sodium sulfonate was within the range of 0.08865mg/ml～0.4432mg/ml（r=0.9999, n=5） .The mean recovery rate was 99.89%（RSD=1.53%, n=9） , CONCLUSION： This method is simple, rapid, accurate, precise, and which can be used as the quality control of carbzocbrome sodium sulfonate for iniection.