PMID: 6171636Aug 1, 1981Paper

High-performance liquid chromatographic determination of components of bleomycin preparations

Journal of Pharmaceutical Sciences
A AszalosT Alexander

Abstract

A fast and sensitive method was developed for the quantitative determination of at least 10 components of pharmaceutical bleomycin sulfate preparations. The method is based on the reversed-phase high-performance liquid chromatographic (HPLC) separation of the components on a muBondapak C18 column with a mobile phase having a linear gradient of 10--40% methanol in aqueous 0.005 M 1-pentanesulfonic acid at pH 4.3. With this assay, the average standard deviations for components A2 and B2 are 0.92 and 0.87, respectively, for a 7.5--22.5 x 10(-3)-mg sample. Regulatory agencies presently use the official Code of Federal Regulations (CFR) method, which is based on CM-Sephadex column chromatography. It was demonstrated that this CFR method does not separate the bleomycin A2 component from some other minor bleomycin components. After elution from the CM-Sephadex column, the "A2 component" was separated into five components by the HPLC method. Bleomycin A2 is stable under these HPLC conditions.

Citations

Jan 1, 1991·Cancer Chemotherapy and Pharmacology·R MahdadiM Lhermitte
Jan 1, 1991·Preparative Biochemistry·C P FreyderL G Marzilli
Jul 31, 2013·International Journal of Biological Macromolecules·Arzum Erdem, Gulsah Congur
May 8, 2016·Biosensors & Bioelectronics·Haimeng PeiFengli Qu
Mar 20, 2014·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Nabil El KatebPierre Faure
Sep 8, 2010·Analytical Chemistry·Bin-Cheng YinBang-Ce Ye

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