Objective To establish an analytical method for determining aristolochic acid components in Zhengtian Capsule.Methods The chromatographic column was Dikma Endeavorsil C18(1.8 μ m.2.1 mm×100 mm),and the mobile phase was acetonitrile and 0.1%formic acid 5 mmol ammonium formate solution as mobile phase by gradient elution.Electro spray positive ion mode(ESI+)and multi reaction monitoring(MRM)mode were used for detection,and the injection volume was 5 μL.The content of aristolochic acid I,aristolochic acid Ⅱ,aristolochic acid Ⅲ a,aristolochic acid AA-Ⅳa,and aristolochic lactam I in Zhengtian Capsule was determined.Results Two types of aristolochic acid substances were detected in 10 batches of samples.The content of aristolochic acid AA-IVa was 0.15-1.03 mg/kg,and the content of aristolochic acid lactam I was 0.40-1.51 mg/kg.Conclusion The method for determining the content of aristolochic acid in Zhengtian Capsules established in this study can provide reference for the clinical application and safety supervision of Zhengtian Capsules and traditional Chinese medicine preparations containing aristolochic acid.
维普
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