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
Tóm tắt
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.
Tài liệu tham khảo
I. N. Glazkov, I. A. Revel’skii, S. V. Kuzyakin, M. P. Kuznetsov, A. A. Bogdanov, A. A. Martynov, I. P. Efimov, and Yu. A. Zolotov, SKF-TP 1(1), 52 (2006).
A. I. Revel’skii and I. A. Revel’skii, in Chromatography for the Benefit of Russia, Collected Vol. (Granitsa, Moscow, 2007), p. 249 [in Russian].
I. A. Revel’skii, Yu. S. Yashin, V. N. Voznesenskii, V. K. Kurochkin, and R. G. Kostyanovskii, USSR Inventor’s Certificate No. 1159412, Byull. Izobret., No. 47 (1985).