摘要
目的建立微波消解-电感耦合等离子体质谱(ICP-MS)测定盐酸黄酮哌酯片中5种重金属元素的含量。方法该药物加入浓硝酸进行微波消解后,ICP-MS法测定As、Cd、Pb、Hg、Ni的含量。结果各元素标准曲线的相关系数都大于0.998,检出限0.001～0.028μg/L,平均加样回收率89.7%～106.7%(RSD<5.0%)。结论盐酸黄酮哌酯片中As、Cd、Pb、Hg、Ni含量均能满足中国药典、美国药典和人用药品注册技术要求国际协调会议的要求。
Objective To establish a method for determination of fve elements in Flavoxate Hydrochloride Tablets by inductively coupled plasma mass spectrometry （ICP-MS） after microwave digestion. Methods After microwave digestion of this drug in concentrated nitric acid, the contents of As, Cd, Hg, Pb and Ni were determined by ICP-MS. Results The correlative coeffcients of standard curves of various elements were found to be more than 0.998, whose detection limits were 0.001-0.028 μg/L, with the average recoveries of 89.7 %-106.7 % （RSD〈5.0 %）. Conclusion All of the contents of As, Cd, Hg, Pb and Ni in Flavoxate Hydrochloride Tablets are kept well within the limits listed in Chinese Pharmacopoeia, United States Pharmacopoeia and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
作者
刘晟
袁莉
LIU Cheng;YUAN Li(Chongqing Institute for Food and Drug Control,Chongqing 401121,China;Chongqing Research Center for Drug Process and Quality Control Engineering,Chongqing 401121,China;Chongqing Huapont Pharmaceutical Co.,Ltd.,Chongqing 401121,China)
出处
《食品与药品》
CAS
2018年第6期428-431,共4页
Food and Drug
关键词
盐酸黄酮哌酯片
重金属
微波消解
电感耦合等离子体质谱法
Flavoxate Hydrochloride Tablets
heavy metal
microwave digestion
inductively coupled plasma mass spectrometry （ICP-MS）
