Accuracy profiles assessing the validity for routine use of high-performance thin-layer chromatographic assays for drug formulations.
J Chromatogr A
; 1293: 159-69, 2013 Jun 07.
Article
en En
| MEDLINE
| ID: mdl-23639129
The accuracy profile, based on total error, integrates several validation parameters, such as trueness, precision and linearity, providing one statistic which enables decision on the suitability of a method for its intended purpose. Two assay methods for formulations are validated using accuracy profiles as an alternative approach to classic method validation. It concerns high-performance thin-layer chromatography (HPTLC) methods, which initially were validated using the classic approach. The first method assayed sulfamethoxazole and trimethoprim, and the second lamivudine, stavudine and nevirapine. Both formulations are fixed-dose combination tablets. The resulting accuracy profiles showed that the 95% ß-expectation tolerance limits for all compounds fell well within the bias acceptance limits set at ±5%. This means that the two analytical thin-layer chromatographic methods are capable of making accurate results at the studied concentration ranges of each compound. Measurement uncertainties of every compound at each concentration level could also be determined from the accuracy profile data.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Cromatografía Líquida de Alta Presión
/
Cromatografía en Capa Delgada
/
Tecnología Farmacéutica
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
J Chromatogr A
Año:
2013
Tipo del documento:
Article
País de afiliación:
Tanzania
Pais de publicación:
Países Bajos