par Shewiyo, D.H.;Dejaegher, Bieke 
;Vander Heyden, Yvan
Editeur scientifique Poole, C. F.
Référence Instrumental thin-layer chromatography, Elsevier, Waltham, MA, page (351-373)
Publication Publié, 2014
;Vander Heyden, YvanEditeur scientifique Poole, C. F.
Référence Instrumental thin-layer chromatography, Elsevier, Waltham, MA, page (351-373)
Publication Publié, 2014
Partie d'ouvrage collectif
| Résumé : | Thin-layer and high-performance thin-layer chromatography (TLC/HPTLC) methods for assaying compound(s) in a sample must be validated to ensure that they are fit for their intended purpose and, where applicable, meet the strict regulatory requirements for controlled products. Two validation approaches are identified in the literature, i.e., the classic and the alternative, which is using accuracy profiles.Detailed procedures of the two approaches are discussed based on the validation of methods for pharmaceutical analysis, which is an area considered having more strict requirements. Estimation of the measurement uncertainty from the validation approach using accuracy profiles is also described.Examples of HPTLC methods, developed and validated to assay sulfamethoxazole and trimethoprim on the one hand and lamivudine, stavudine, and nevirapine on the other, in their fixed-dose combination tablets, are further elaborated. |
