高效液相色谱法测定炎琥宁注射液中脱水穿心莲内酯琥珀酸半酯含量

摘要

目的：建立测定炎琥宁注射液中脱水穿心莲内酯琥珀酸半酯含量的高效液相色谱法。方法以 Agilent C18柱(250 mm ×4.6 mm，5μm)为色谱柱，乙腈－0.05 mol / mL 磷酸二氢钾溶液(35：65)为流动相，检测波长为251 nm，流速为1.0 mL / min。结果脱水穿心莲内酯琥珀酸半酯质量浓度在40~400μg / mL 范围内与峰面积积分线性关系良好，平均回收率为98.39%，RSD =0.64%( n =9，r =0.9999)。结论该法能有效控制炎琥宁注射液中脱水穿心莲内酯琥珀酸半酯的质量，简单、准确、灵敏度高。%Objective To determine the content of dehydroandrographolide succinate in Potassium Sodium Dehydroandroandrographolide Succinate Injection by HPLC. Methods The determination was performed on the Agilent C18 column with acetonitrile - 0. 05 mol / mL potassium dihydrogen phosphate(35 : 65 ) as the mobile phase at a flow rate of 1. 0 mL / min and the detection wavelength of 251 nm. Results Dehydroandrographolide succinate in the range of 40 - 400 μg / mL showed the good linear relation with the peak area, the av-erage recovery rate was 98. 39% , RSD = 0. 7% ( r = 0. 999 9,n = 9) . Conclusion This quality control method can effectively control the quality of dehydroandrographolide succinate in Potassium Sodium Dehydroandroandrographolide Succinate Injection, which is simple with accurate results and high sensitivity.