摘要
Abstract
An inductively coupled plasma mass spectrometry(ICP-MS)method was established to measure the contents of eight elemental impurities(Cd,Pb,As,Hg,Co,V,Ni,Ti)in tenofovir disofuroxil fumarate.The samples were obtained by wet digestion,and subsequently analyzed by ICP-MS with scandium,germanium,rhodium and bismuth as internal standards.The assay was carried out using helium determination mode and argon as the carrier gas.The sampling depth was 10.0 mm,the RF power was 1550 W,the atomizing gas was 1.07 L/min,the peristaltic pump speed was 0.10 r/s,and the collection was repeated for 6 times.The linearity of the eight elemental impurities was excellent,with the correlation coefficients(r)＞0.999 1.The average recoveries were 89.1％～100.4％with relative standard deviation(RSD)＜4.8％.Precision(repeatability,intermediate precision)RSD＜3.7％.The elemental impurities in 6 batches of samples were accordingly analyzed,and their contents proved to be within the allowable limits.Due to the good specificity,high accuracy and sensitivity,our new method can be applied for the determination of elemental impurities in tenofovir dipyrofure fumarate.关键词
富马酸替诺福韦二吡呋酯/湿法消解/元素杂质/电感耦合等离子体质谱Key words
tenofovir disoproxil fumarate/wet digestion/elemental impurities/inductively coupled plasma mass spectrometry(ICP-MS)分类
药学
