高效液相色谱法测定穿琥宁氯化钠注射液中的含量及有关物质

目的制定穿琥宁氯化钠注射液含量及有关物质的测定方法。方法采用高效液相色谱法测定,phenomenex C18色谱柱,流动相为甲醇-0.05%磷酸二氢钾溶液(用磷酸调pH值为3.0)(60∶40);检测波长:251nm,柱温:30℃,流速:1.0mL/min。结果穿琥宁在21.6～432.0μg/mL浓度范围内线性关系量良好(r=0.9993),日内、日间精密度试验RSD分别<0.55%和<1.08%,回收率为99.83%(RSD=0.30%)。结论该方法可作为穿琥宁氯化钠注射液的质量控制方法。

Determination of the Content of Potassium Dehydrographolide Succinate in Potassium Dehydroandrographolide Succinate and Sodium Chlorade Injection and Its Related Substance by HPLC

Objective To establish an HPLC method to determinate the content of potassium Dehydrographolide Succinate in Potassium Dehydroandrographolide Succinate and Sodium chlorade injection and Its related substance. Methods An optimal HPLC mathed was set up. The separation was performed on Diamonsil TM C18 column. The mobile phase was composed of methanol-0.05mol · L^-1 potassium dihydrogen phosphate solution-diethylamine （pH adjusted to 3.0） by H2PO4 ] （60：40） with the flow rate of 1.0 mL · min^-1 ,and the detective wavelength was 251 nm and the teperarure was 3022. Results There was a good linearity within 21.6 - 432.0 μg/mL of potassium sodium dehydroandran drographolide succinate （ r = 0. 9993 ）. The average recovery was 99.83 % （ RSD =0.3% ）. Conclusion This method could be used to control the quality of Potassium Dehydroandrographolide Succinate and Sodium chlorade injection.