Amfotericin B tartalmú készítmények kvantitatív analízisének kémiai és mikrobiológiai vonatkozásai

Fittler András, Matus Zoltán, Kocsis Béla, Botz Lajos

Research output: Article

Abstract

Amphotericin B can be determined by chemical (HPLC, spectrophotometry) and microbiological (bioassay) methods. The utilization of both during a stability test can give more detailed information about the activity and concentration change of amphotericin B solutions. Previously published HPLC methods do not lay stress on the separation of by-constituents present in the substance. We have also observed that the bioassay conditions described in the Ph. Eur. 6. are not suitable for the measurement of concentration change experienced during a stability test. The aim of our study was to optimize the chemical and microbiological methods. We have improved the eluent system based on earlier HPLC methods for the separation of the main heptaene and the minor tetraene by-constituents in Fungizone (Bristol-Myers Squibb). The most optimal bioassay conditions were determined where a relatively wide concentration range can be measured. With the improved methods both chemical and microbiological changes can be more accurately measured in our future stability tests.

Translated title of the contributionChemical and microbiological aspects of the quantitative analysis of amphotericin B
Original languageHungarian
Pages (from-to)95-102
Number of pages8
JournalActa pharmaceutica Hungarica
Volume78
Issue number3
Publication statusPublished - nov. 10 2008

ASJC Scopus subject areas

  • Pharmaceutical Science

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