摘要
目的:建立胃康灵胶囊中金胺O染色物的检测方法,并对其进行筛查,同时建立阳性样品中金胺O的含量测定方法。方法:采用UPLC-PDA法对胃康灵胶囊中的金胺O进行筛查,并采用UPLC-MS/MS二级质谱对阳性样品进行确证。结果:对来自37家企业的123批次样品进行筛查和确认发现:有6家企业的23批次样品中检出金胺O;金胺O进样在0.42~208.72 ng的范围内有良好的线性关系。胃康灵胶囊阳性样品中金胺O的含量在1.0~28.7μg·粒^(-1)。结论:本方法准确可靠,可作为胃康灵胶囊中金胺O染色物的检测方法。
Objective： To establish a method for detecting,screening and quantifying the possibly exiting auramine O in weikangling capsule. Methods： UPLC-PDA was used as a screening method for auramine O. The positive results were further confirmed by UPLC-MS /MS. Results： 123 batches of weikangling capsules from 37 manufactories were detected and confirmed： auramine O was detected from 23 batches of samples in 6 manufactories. Auramine O had considerable linear relationship in the range of 0. 42 ~ 208. 72 ng. The contents of auramine O in positive samples were in the range of 1. 0 ~ 28. 7μg per capsule. Conclusion： This method is accurate and reliable,and can be used as the detection method for auramine O in weikangling capsule.
出处
《中国药物评价》
2016年第2期77-80,共4页
Chinese Journal of Drug Evaluation
