HPLC同时测定复尔康注射液中3种活性成分的含量

Simultaneous Determination of Three Active Constituents in Fuerkang Injection by HPLC

目的建立同时测定复尔康注射液中甘草酸铵、蒿酮和维A酸含量的HPLC分析方法。方法色谱柱:Dikma KromasilC18(4.6mm×250mm,5μm)色谱柱;流动相:乙腈-0.1%磷酸溶液,梯度洗脱;分段变波长测定;柱温:30℃;流速:1.0mL·min-1。结果甘草酸铵、蒿酮和维A酸的线性范围分别为:0.249～1.992μg(r=0.9999),0.4409～3.5272μg(r=0.9999)、0.138～1.104μg(r=0.9999)。平均回收率分别为98.89%,99.17%,99.02%,RSD为0.67%,0.59%,0.74%。结论该方法简便、快速、准确、具有良好的重复性和回收率,可作为该制剂的质量控制标准。

OBJECTIVE To establish a HPLC method for the simultaneous determination of ammonium glycyrrhizinate, artemisia ketone and tretinoin in Fuerkang injection. METHODS The separation was carried out on a Dikma Kromasil C18 column （4.6 mm× 250 mm, 5 μm）. The mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution and changeable wavelength detection. The column temperature was 30 ℃. The flow rate was 1.0 mL.min^-1. RESULTS The calibration curves were linear in the ranges of 0.249-1.992μg （r= 0.999 9） for ammonium glycyrrhizinate, 0.440 9- 3.527 2 μg （r= 0.999 9） for artemisia ketone, 0.138-1.104 μg （r= 0.999 9） for tretinoin. The average recoveries were 98.89 % with RSD 0.67 % for ammonium glycyrrhizinate, 99.17% withRSD 0.59% for artemisia ketone, 99.02% with RSD 0.74% for tretinoin. CONCLUSION This method is simple, rapid, accurate and with good repeatability and recovery, it can be used as a quality control method for this preparation.