中国药业2025，Vol.34Issue(22)：81-85,5.DOI:10.3969/j.issn.1006-4931.2025.22.017
超高效液相色谱串联质谱法检测小儿咳喘灵口服液中山银花
Determination of Lonicerae Flos in Xiaoer Kechuanling Oral Liquid by UPLC-MS/MS
摘要
Abstract
Objective To establish a method for detecting adulteration of Lonicerae Flos in Xiaoer Kechuanling Oral Liquid.Methods An ultra-high performance liquid chromatography-mass spectrometry(UPLC-MS/MS)method was used to determine the content of macranthoidin B(MB)in the preparation.Chromatographic conditions as follows:the chromatographic cloumn was Waters ACQUITY UPLC® BEH C18 column(200 mm×2.1 mm,1.7 µm),the mobile phase was 0.1%formic acid solution(containing 8 mmol/L ammonium formate)-acetonitrile(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 35℃,and the injection volume was 5 µL;mass spectrometry conditions as follows:electrospray ionization(ESI)source,with negative ion scanning,and multiple reaction monitoring(MRM)mode were used.The quantitative ion pair of MB was m/z 1 397.5 → 1 074.5.Results The linear range of MB was 0-9.214 µg/mL(r≥0.999 3).The RSDs of precision,stability and repeatability test were all lower than 5.0%;the average recovery rate was 93.63%,with RSD of 4.35%(n=9).MB was detected in 19 of 29 batches of samples,but the content was lower than the proposed limit of impurity.Conclusion The method has strong specificity,high sensitivity,fast analysis speed,stable and reliable,which can effectively monitor the adulteration of Lonicerae Flos in Xiaoer Kechuanling Oral Liquid,and can be used for quality control of the preparation.关键词
小儿咳喘灵口服液/灰毡毛忍冬皂苷乙/山银花/掺伪/杂质限度Key words
Xiaoer Kechuanling Oral Liquid/macranthoidin B/Lonicerae Flos/adulteration/limit of impurity分类
医药卫生引用本文复制引用
谢婷,周云峰,廖圆月,彭真,黄招光..超高效液相色谱串联质谱法检测小儿咳喘灵口服液中山银花[J].中国药业,2025,34(22):81-85,5.基金项目
江西省宜春市科技计划项目[2023ZDJH2693]. （）
