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目的:建立痛泄胶囊中升麻素苷、5-O-甲基维斯阿米醇苷和芍药苷含量测定的方法。方法:采用高效液相色谱法在同一色谱条件下[色谱柱:Waters Symmetry C18(250mm×4.6mm,5μm)流动相:乙腈-0.1%磷酸梯度洗脱;流速:1.0ml/min;柱温:30℃]对制剂中3种成分进行定量测定。结果:升麻素苷在47.88~718.2ng范围内线性关系良好,r=0.999 9,平均回收率为99.88%(n=9),RSD为1.08%;5-O-甲基维斯阿米醇苷在47.52~712.8ng范围内线性关系良好,r=0.999 9,平均回收率为99.68%(n=9),RSD为0.82%;芍药苷在51~765ng范围内线性关系良好,r=0.999 9,平均回收率为100.82%(n=9),RSD为0.91%。结论:所建立的方法可在同一色谱条件下检测出3个成分,可用于该制剂的质量控制。
Objective: To establish a method for determination of content of ciminoside, 5-O-methylvishisainin and paeoniflorin in Tongxie capsule. Methods: HPLC was used under the same chromatographic conditions [column: Waters Symmetry C18 (250 mm × 4.6 mm, 5 μm) mobile phase: acetonitrile-0.1% phosphoric acid gradient elution; flow rate: 1.0 ml / 30 ° C] The three components in the formulation were quantitatively determined. Results: The content of ciclinoid in the range of 47.88 ~ 718.2ng was good, r = 0.999 9, the average recovery was 99.88% (n = 9), RSD was 1.08% The linear range was 47.52 ~ 712.8ng, r = 0.999 9, the average recovery was 99.68% (n = 9), RSD was 0.82%. Paeoniflorin showed good linearity in the range of 51 ~ 765ng with r = 0.999 9 The average recovery was 100.82% (n = 9) with a RSD of 0.91%. Conclusion: The established method can detect three components under the same chromatographic conditions and can be used for the quality control of the preparation.