Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume
38, Number 8, August 2000, pp. 338-344
High-Performance
Liquid Chromatographic Determination of Amphotericin B in a Liposomal Pharmaceutical
Product and Validation of the AssayT.
Eldem
Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Biotechnology,
06100 Ankara, Turkey
N. Arican-Cellat
Refik Saydam Central Institute of Hygiene (RSMHE), Drugs and Cosmetics Research
Department, 06100 Ankara, Turkey
A
validated high-performance liquid chromatographic method is presented to quantitate
amphotericin B (AB) in a liposomal pharmaceutical formulation. The analysis
is based on the chromatographic separation of AB and 1-amino-4-nitronaphthalene
(the internal standard) on a C18 µBondapac reversed-phase column with
a mobile phase consisting of a mixture of acetonitrile and 0.02M ethylenediamine
tetra-acetic acid disodium salt at pH 5.0 (45:55, v/v). The chromatographic
analysis time is less than 10 min, and the validation of the assay shows that
it is selective, accurate, and linear for the concentration range of 2.50 to
7.50 µg/mL with a detection limit of 0.00500 µg/mL. The within-day
and between-day relative standard deviation values are 1.26% (n = 18) and 1.25%
(n = 8), respectively. The method described conforms to the validation of compendial
methods used for finished pharmaceutical products in general and offers a reliable,
quick, and cost-effective procedure for examining the consistency or quality-control
analysis of AB in liposomal products. It can also be applied for the determination
of AB in other nonliposomal lipid-based drug delivery systems that are on the
market.
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