A new approach to comparison of original pharmaceuticals and generics based on comparison of multidimensional impurity profiles using supercritical fluid extraction, liquid extraction, and GC-MS

被引:0
|
作者
Revel'skii, A. I. [1 ]
Glazkov, I. N. [1 ]
Yashin, Yu. S. [1 ]
Chepelyanskii, D. A. [1 ]
Samokhin, A. S. [1 ]
Burmykin, D. A. [1 ]
Revel'skii, I. A. [1 ]
机构
[1] Moscow MV Lomonosov State Univ, Fac Chem, Moscow, Russia
关键词
impurities in pharmaceuticals; generics; GC-MS; reaction GC-MS; supercritical fluid extraction; liquid extraction; mass spectrometry with atmospheric pressure photochemical ionization;
D O I
10.1134/S1990793111080094
中图分类号
O64 [物理化学(理论化学)、化学物理学]; O56 [分子物理学、原子物理学];
学科分类号
070203 ; 070304 ; 081704 ; 1406 ;
摘要
This paper reports on our effort to study the possibility of comparing the original pharmaceuticals and their analogs (generics) based on comparisons of the multidimensional profiles of impurities isolated from samples by supercritical fluid extraction and liquid extraction and recorded by gas chromato-mass spectrometry (GC-MS) with electron ionization (EI) and atmospheric pressure photochemical ionization (APPhCI). Using the suggested approach makes it possible to increase the number of recorded impurities, to show that the pharmaceutical samples are authentic, and to compare the original pharmaceuticals and generics according to their quality.
引用
收藏
页码:1245 / 1249
页数:5
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