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Volume 45, Number 1
(January - February 2000) |
Remarks on the USP Recommendations for Quantitative Determination of Idarubicin Hydrochloride by HPLC
by Anna Kalska-Kowalska, Iwona Cendrowska, Hanna Beczkowicz, Anna Cholewinska, Joanna Zagrodzka, Jan Ramza and Grzegorz Grynkiewicz
Pharmaceutical Research Institute, 8 Rydygiera Str., 01-793 Warsaw, Poland
Key words: idarubicin quantification, reverse-phase column chromatography, HPLC
A discrepancy between the official requirements (USP 23 and USP 24) for experimental conditions set for idarubicin hydrochloride certification by high-performance reverse-phase liquid chromatography and characteristics of the commercially available columns is poited out and discussed in some detail. Based on experimental findings a switch from C-1 to C-18 has been recommended for accurate and reproducible idarubicin hydrochloride determination.