甘草酸铵类制剂中甘草酸差向异构体的分析

目的: 建立一种方法并依据这种方法分析甘草酸铵类制剂中18α-甘草酸和18β-甘草酸2种差向异构体的含量。 方法: 采用Kromasil C₁₈(250 mm×4.6 mm,5 μm)色谱柱,以0.05 mol·L^-1磷酸盐缓冲液(调节pH至7.0)-乙腈(80: 20)为流动相,流速1 mL·min^-1,检测波长252 nm。 结果: 18α-甘草酸和18β-甘草酸的线性范围分别为0.025~2.500 mg·mL^-1(r=0.9990)和0.025~2.000 mg·mL^-1(r=0.9990),平均加样回收率(n=9)分别为99.0%和102.5%。同一色谱图中,2个色谱峰间的分离度大于1.5。 结论: 所建方法可用于分析甘草酸铵类制剂中甘草酸差向异构体的含量,甘草酸铵类制剂中18α-甘草酸和18β-甘草酸比例不一,应完善标准加以控制。

Objective: To establish a method for the determination of 2 epimers in ammonium glycyrrhizinate drugs. Methods: Kromasil C₁₈(250 mm×4.6 mm,5 μm)column was adopted,and the mobile phase consisted of 0.05 mol·L^-1 PBS(pH 7.0)-acetonitrile(80: 20)at a flow rate of 1 mL·min^-1.The detection wavelength was 252 nm. Results: :The linearity ranges of 18α-GL and 18β-GL were 0.025-2.500 mg·mL^-1(r=0.9990)and 0.025-2.000 mg·mL^-1(r=0.9990).Good recoveries and resolutions had been got. Conclusion: An accurate method has been established to analyze epimers in ammonium glycyrrhizinate drugs,their standards should be enhanced as soon as possible.

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