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Arhiv za farmaciju
2012, vol. 62, iss. 5, pp. 475-488
article language: Serbian
Professional Paper

Robustness testing of liquid chromatographic method for determination of itraconazole and its impurities applying fractional factorial design
aUniverzitet u Banjoj Luci - Medicinski fakultet, Katedra za analitiku lijekova, Banja Luka, Republika Srpska, BiH
bUniverzitet u Beogradu, Farmaceutski fakultet, Institut za farmaceutsku hemiju i analitiku lekova

e-mail: jancic.stojanovic@pharmacy.bg.ac.rs

Project

Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (MESTD - 172052)

Abstract

Test of robustness is a part of the method validation and it is carried out in the end of the method development or in the beginning of the method validation. The purpose of robustness testing is to avoid problems in interlaboratory studies and to define parameters with the greatest impact on the method. The chosen factors are investigated within the range that slightly exceeds the expected variations when the method is transferred from one instrument/laboratory to another. The application of experimental design is recommended to perform robustness testing and two most often utilized - Plackett-Burman and fractional factorial design - are described. Furthermore, the manners of evaluation of factor significance, the methods for calculation of the range of insignificance for significant factors and the procedure for determination of system suitability test parameters are described. Such an approach of robustness testing was applied to the high performance liquid chromatographic method for determination of itraconazole and its impurities B and F. The robustness is tested by using fractional factorial design and 4 factors in 11 experiments were analyzed. After the application and the analysis of all the suggested steps for robustness, the impact of factors on the system responses was evaluated, insignificance ranges were defined and system suitability test limits for suggested method were determined.

Keywords

References

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