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目的:建立检测消风止痒颗粒中马兜铃酸A的液相色谱-质谱分析方法。方法:采用Venusil mp C18(250 mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.1%甲酸水溶液(40∶60),流速1.0 mL.min-1。采用电喷雾电离源正离子质谱检测。结果:马兜铃酸A在0.005086～0.4069μg范围内线性关系良好(r=1.000),平均回收率(n=7)为97.1%(RSD=2.1%)。87批制剂均未检出马兜铃酸A。结论:本法快速、灵敏、准确,可用于消风止痒颗粒中是否混入关木通的确证检查,以防马兜铃酸A造成的用药安全,为消风止痒颗粒的质量控制提供了科学依据。
Objective: To establish a liquid chromatography - mass spectrometry method for the determination of aristolochic acid A in Xiaofengzhiyang granules. Methods: Venusil mp C18 (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-0.1% formic acid solution (40:60) and the flow rate was 1.0 mL.min-1. Electrospray ionization source positive ion mass spectrometry was used. RESULTS: Aristolochic acid A had a good linearity (r = 1.000) in the range of 0.005086 to 0.4069 μg with an average recovery of 97.1% (n = 7) (RSD = 2.1%). No aristolochic acid A was detected in 87 batches. Conclusion: The method is rapid, sensitive and accurate and can be used to confirm whether the Xiaofengzhiyang granule is mixed with Guanmu Tong in order to prevent the medication safety caused by aristolochic acid A. It provides a scientific basis for the quality control of Xiaofengzhiyang granule. .