妇必舒阴道泡腾片中苦参碱、欧前胡素和蛇床子素的含量测定

Determination of Matrine, Imperatorin and Osthole in Fubishu Vaginal Effervescent Tablets

关键词:  妇必舒阴道泡腾片  苦参碱  欧前胡素  蛇床子素  高效液相色谱法

Key words:  Fubishu Vaginal effervescent tablets  matrine  imperatorin  osthole  HPLC

摘要:

目的 采用HPLC测定妇必舒阴道泡腾片中苦参碱、欧前胡素和蛇床子素的含量。方法 苦参碱色谱条件Kromasil 100-5 C₁₈色谱柱(250 mm×4.6 mm，5 μm)，柱温30 ℃，流动相为乙腈-0.1%磷酸溶液(用三乙胺调节pH值至7.6)(17∶83)，检测波长为220 nm；流速为1 mL·min^-1；欧前胡素、蛇床子素色谱条件：色谱柱为Agela Innoval C₁₈(250 mm×4.6 mm，5 μm)，柱温30 ℃，流动相为乙腈-水(65∶35)；检测波长为248 nm；流速为1 mL·min^-1。 结果 苦参碱、欧前胡素和蛇床子素线性范围分别为156.0~3 120.0 ng，10.26~256.50 ng和36.98~924.50 ng(r=1.000 0)，平均回收率分别为97.0%，102.8%和99.5%，RSD值分别为1.8%，0.7%和0.3%。结论 该方法简便，结果准确，重现性好，可用于妇必舒阴道泡腾片的质量控制。

Abstract:

OBJECTIVE To determine matrine, imperatorin and osthole in Fubishu Vaginal effervescent tablets by HPLC. METHODS The Kromasil 100-5 C₁₈(250 mm×4.6 mm, 5 μm)column with temperature at 30 ℃ was used to separate matrine. The mobile phase was acetonitrile-0.1% phosphoric acid solution(adjust the pH to 7.6 with triethylamine)(17∶83), the detection wavelength was 220 nm, the flow rate was 1.0 mL·min^-1. The Agela Innoval C₁₈(250 mm×4.6 mm, 5 μm)column with temperature at 30 ℃ was used to separate imperatorin and osthole. The mobile phase was acetonitrile-water(65∶35), the detection wavelength was 248 nm, the flow rate was 1.0 mL·min^-1. RESULTS A good linear relationships were obtained in the following range, matrine 156.0-3 120.0 ng, imperatorin 10.26-256.50 ng and osthole 36.98-924.50 ng(r=1.000 0). The average recoveries were 97.2%, 102.8% and 99.5%, respectively, and RSDs were 1.8%, 0.7% and 0.3%. CONCLUSION The method is simple, accurate, reproducible, and it can be applied to control the quality of the Fubishu Vaginal effervescent tablets.