HPLC测定利胆止痛胶囊中芍药苷的含量

Determination of Paeniflorin Content in Lidan Zhitong Capsules by HPLC

目的:提高利胆止痛胶囊质量标准,增加含量测定项以对药品进行更好的质量控制。方法:采用HPLC对制剂方中赤芍进行含量测定。安捷伦Agilent Extend-C18(4 mm×250 mm,5μm)色谱柱,流动相乙腈-0.1%磷酸溶液(15∶85),检测波长230 nm,流速1 mL·min-1,理论板数按芍药苷峰计算应不低于4 000。结果:芍药苷在0.144～0.720μg呈良好的线性关系,精密度试验RSD 0.54%,样品在24 h内基本稳定(RSD 1.17%),重复性试验RSD 1.48%,平均加样回收率为97.77%(RSD 1.48%)。依正文方法进行了10批样品的含量测定,利胆止痛胶囊芍药苷的平均含量0.772 0 mg/粒。结论:该方法专属性强,灵敏度高、重复性好,可用于该制剂的质量控制。

Objective： To establish a HPLC method for determining paeoniflorin content in Lidan Zhitong capsules. Method： The content of paeoniflorin from Radix paeoniad rubra was idetermined by HPLC. The Agilent Extend-Cls column （4 mm ~250 mm, 5 Izm） was used with acetonitrile-0. 1% phosphoric acid solution （15： 85） as mobile phase; the detection wavelength was set at 230 nm; flow rate was 1 mL.min-l. Number of theoretical plates by paeoniflorin peak calculation should not be less than 4 000. Result： The calibration curve of paeoniflorin was linear in the range of 0. 144-0. 720 μg. RSD of precision was 0. 54%. RSD of stability was 1.17%. RSD of reproducibility was 1.48%. The average recovery was 97.77% with RSD of 1.48%. Conclusion： The method is selective and sensitive, can be used for quality of control of Lidan Zhitong capsule.