Author/Authors :
Dehouck، نويسنده , , P. and Vander Heyden، نويسنده , , Y. and Smeyers-Verbeke، نويسنده , , Paul J. and Massart، نويسنده , , D.L. and Marini، نويسنده , , R.D. and Chiap، نويسنده , , P. and Hubert، نويسنده , , Ph. and Crommen، نويسنده , , J. and Van de Wauw، نويسنده , , W. and De Beer، نويسنده , , J. and Cox، نويسنده , , R. and Mathieu، نويسنده , , G. and Reepmeyer، نويسنده , , J.C. and Voigt، نويسنده , , B. and Estevenon، نويسنده , , O. and Nicolas، نويسنده , , A. and Van Schepdael، نويسنده , , A. and Adams، نويسنده , , E. and Hoogmartens، نويسنده , , J.، نويسنده ,
Abstract :
Erythromycin is a mixture of macrolide antibiotics produced by Saccharopolyspora erythreas during fermentation. A new method for the analysis of erythromycin by liquid chromatography has previously been developed. It makes use of an Astec C18 polymeric column. After validation in one laboratory, the method was now validated in an interlaboratory study. Validation studies are commonly used to test the fitness of the analytical method prior to its use for routine quality testing. The data derived in the interlaboratory study can be used to make an uncertainty statement as well. The relationship between validation and uncertainty statement is not clear for many analysts and there is a need to show how the existing data, derived during validation, can be used in practice. Eight laboratories participated in this interlaboratory study. The set-up allowed the determination of the repeatability variance, s2r, and the between-laboratory variance, s2L. Combination of s2r and s2L results in the reproducibility variance s2R. It has been shown how these data can be used in future by a single laboratory that wants to make an uncertainty statement concerning the same analysis.
