高效液相色谱-质谱联用技术测定妇科止带片中龟甲胶成分  

Determination of Tortoise-shell GelatinIngredients in Fuke Zhidai Tablets by LC-MS/MS

作　　者：陈鸿玉[1,2] 李文莉[1,2] 李劲平[1] 丁野 舒毕琼 杨清 童达 孙辉 高洁莹 

机构地区：[1]中南大学药学院,长沙410013 [2]湖南省药品检验研究院,长沙410001

出　　处：《中国药品标准》2017年第2期95-98,共4页Drug Standards of China

基　　金：国家科技重大专项课题(编号:2014ZX09304307-002);2015年度国家药品计划抽验任务;湖南省食品药品监督管理局食品药品安全科技项目"含龟甲胶中成药中龟甲胶的检测方法研究"(湘食药科R201504)

摘　　要：目的:建立妇科止带片中龟甲胶成分的检测方法。方法:利用超高效液相色谱-质谱联用技术对妇科止带片中龟甲胶的特征分子离子峰进行检测,选择龟甲胶特征分子离子峰m/z 631.3(双电荷)→546.4和m/z 631.3(双电荷)→921.4作为检测离子对,离子化模式为ESI^+,进行多反应监测。结果:36批市售样品中均可检出龟甲胶的特征分子离子峰。结论:经方法学验证,所建方法专属性强,可用于妇科止带片中龟甲胶成分的检测,为妇科止带片的质量控制提供参考。Objective： To establish a method for determination of tortoise-shell gelatin ingredients in Fuke Zhidai Tablets. Methods： The characteristic molecular ion peaks of tortoise-shell gelatin in Fuke Zhidai Tablets were determined by the ultra performance liquid chromatography （UPLC） coupled to triple quadrupole mass spectrometer （TQMS）. The characteristic ion pairs of tortoise-shell gelatin m/z 631.3 →546. 4 and m/z 631.3 →921.4 were as detection ion pairs. The positive electrospray ionization and multiple reaction monitoring were adopted. Results： The characteristic molecular ion peaks of tortoise-shell gelatin were detected in all thirty-six batches of commercial samples. Conclusion： The method was validated and had the good specificity. It is applicable to determination of tortoise-shell gelatin ingredients in Fuke Zhidai Tablets. The method can be the scientific reference for quality control of Fuke Zhidai Tablets.

关 键 词：高效液相色谱-质谱联用 妇科止带片 龟甲胶 特征分子离子峰 

分 类 号：R921.2[医药卫生—药学]