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目的:用RP-HPLC法测定甘利欣注射液中18α-甘草酸和18β-甘草酸的含量。方法:采用ZOR-BAX Extend C18分析柱(4.6mm×250mm,5μm);乙腈-磷酸盐缓冲液(pH=7:20:80)为流动相;检测波长250nm;流速1mL.min-1;柱温为30℃。取混合对照品溶液及供试品溶液,分别注入液相色谱仪,以混合对照品溶液色谱图中18α-甘草酸和18β-甘草酸的峰面积(3次平均)外标法计算甘利欣中18α-甘草酸和18β-甘草酸的含量。结果:18α-甘草酸和18β-甘草酸分别在0.1010～1.0100μg(r=0.99984)和0.1033～1.0330μg(r=0.99948)范围内呈线性;18α-甘草酸和18β-甘草酸加样回收率和RSD分别为98.02%、RSD=0.35%和97.5%、RSD=0.54%。结论:对于提高甘利欣注射液药品质量标准,该方法更加简便、可靠、准确,具有定性、定量双重意义。
Objective: To determine the content of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid in Ganlixin injection by RP-HPLC. METHODS: A ZOR-BAX Extend C18 column (4.6 mm×250 mm, 5 μm) was used; acetonitrile-phosphate buffer (pH=7:20:80) was used as mobile phase; detection wavelength was 250 nm; flow rate was 1 mL.min-1; The temperature is 30°C. Take the mixed reference solution and the test solution, and inject them into the liquid chromatograph. Calculate the peak area (3 times average) of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid in the chromatogram of the mixed reference solution. The content of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid. Results: 18α-glycyrrhizic acid and 18β-glycyrrhizic acid were linear in the range of 0.1010-1.0100 μg (r=0.99984) and 0.1033-1.0330 μg (r=0.99948),respectively; the recovery of 18α-glycyrrhizic acid and 18β-glycyrrhizic acid was obtained. And RSD were 98.02%, RSD=0.35% and 97.5%, RSD=0.54%, respectively. Conclusion: To improve the drug quality standard of Ganlixin injection, the method is more simple, reliable, accurate, and has the dual meaning of qualitative and quantitative.