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J Pharm Biomed Anal. 2010 Sep 21;53(1):109-12. doi: 10.1016/j.jpba.2010.03.012. Epub 2010 Mar 17.

An interlaboratory study on the suitability of a gradient LC-UV method as a compendial method for the determination of erythromycin and its related substances.

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1
Katholieke Universiteit Leuven, Laboratorium voor Farmaceutische Analyse, Faculteit Farmaceutische Wetenschappen, O & N 2, Herestraat 49 (PB 923), B-3000 Leuven, Belgium.

Abstract

A liquid chromatographic (LC) method for the analysis of erythromycin and related substances has been adapted from an isocratic method developed by Chepkwony et al. (2001). The suitability of the method for general application as a compendial (pharmacopoeia) method has been assessed by means of an interlaboratory (collaborative) study. The method involves LC separation on a XTerra C18 column kept at 65 degrees C and UV detection at 210 nm. Five laboratories, located in Europe and the United States (US), participated in the study. Four erythromycin samples were tested. The main components (erythromycin A (EA), erythromycin B (EB), erythromycin C (EC)) and the impurities were determined. The analysis of variance was carried out on the results of the five laboratories to evaluate the between-laboratory consistencies and the laboratory-sample interaction. The estimates for the repeatability and reproducibility of the method, expressed as relative standard deviation (RSD) of the result of the determination of EA, were calculated to be 0.8% and 1.4% respectively. It is concluded that the method examined is a good replacement for the methods currently described in the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP), especially for its enhanced selectivity.

PMID:
20381987
DOI:
10.1016/j.jpba.2010.03.012
[Indexed for MEDLINE]

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