HPLC法同时测定喜炎平注射液中4个有效成分的含量

目的: 建立高效液相色谱法同时测定喜炎平注射液中4个有效成分的含量。方法: 采用Diamonsil C₁₈(250 mm×4.6 mm,5 μm)色谱柱,以磷酸二氢钾缓冲液(每1000 mL水中加入磷酸二氢钾1.361 g与庚烷-1-磺酸钠1.0 g)为流动相A,乙腈为流动相B,进行梯度洗脱,流速1.0 mL·min^-1,检测波长225 nm,柱温25 ℃。结果: 穿心莲内酯硫酸酯化物A、穿心莲内酯硫酸酯化物B、穿心莲内酯硫酸酯化物C、9-脱氢-17-氢-穿心莲内酯进样浓度分别在31.53~63.05 μg·mL^-1(r=0.9999),31.35~62.70 μg·mL^-1(r=0.9998),31.90~63.80 μg·mL^-1(r=0.9999),31.32~62.65 μg·mL^-1(r=0.9999)范围内线性关系良好;平均回收率(n=9)分别在98.2%~100.5%之间。结论: 该方法准确,灵敏度高,可作为控制喜炎平注射液质量标准控制的方法。

Objective: To develop an HPLC method for simultaneous determination of four effective ingredients in Xiyanping injection. Methods: Analysis was performed on a Diamonsil C₁₈(250 mm×4.6 mm,5 μm) column eluted with water containing potassium dihydrogen phosphate and heptane-1-sulfonic acid sodium(A) and acetonitrile(B) in a gradient program. The flow rate was 1.0 mL·min^-1,the detection wavelength was 225 nm,and the column temperature was 25 ℃. Results: Andrographolide sulfate A(ASA),andrographolide sulfate B(ASB),andrographolide sulfate C(ASC) and 9-dehydro-17-hydro-andrographolide(DHA) showed good linearity in the ranges of 31.53-63.05 μg·mL^-1(r=0.9999),31.35-62.70 μg·mL^-1(r=0.9998),31.90-63.80 μg·mL^-1(r=0.9999),and 31.32-62.65 μg·mL^-1(r=0.9999). The average recoveries,measured at three concentration levels,varied from 98.2% to 100.5%. Conclusion: The method is simple,sensitive and accurate,which can be used for the quality control of Xiyanping injection.

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