Estimation of uncertainty from method validation data: Application to a reverse-phase high-performance liquid chromatography method for the determination of amino acids in gelatin using 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate reagent.
J Pharm Biomed Anal
; 129: 389-397, 2016 Sep 10.
Article
em En
| MEDLINE
| ID: mdl-27454091
ABSTRACT
A detailed procedure for estimating uncertainty according to the Laboratory of Government Chemists/Valid Analytical Measurement (LGC/VAM) protocol for determination of 18 amino acids in gelatin is proposed. The expanded uncertainty was estimated using mainly the method validation data (precision and trueness). Other sources of uncertainties were contributed by components in standard preparation measurements. The method scope covered a single matrix (gelatin) under a wide range of analyte concentrations. The uncertainty of method precision, µ(P) was 0.0237-0.1128pmolµl(-1) in which hydroxyproline and histidine represented the lowest and highest values of uncertainties, respectively. Proline and phenylalanine represented the lowest and highest uncertainties value for method recovery, µ(R) that was estimated within 0.0064-0.0995pmolµl(-1). The uncertainties from other sources, µ(Std) were 0.0325, 0.0428 and 0.0413pmolµl(-1) that were contributed by hydroxyproline, other amino acids and cystine, respectively. Hydroxyproline and phenylalanine represented the lowest and highest values of expanded uncertainty, U(y) that were determined at 0.0949 and 0.2473pmolµl(-1), respectively. The data were accurately defined and fulfill the technical requirements of ISO 170252005.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Carbamatos
/
Gelatina
/
Aminoácidos
/
Aminoquinolinas
Idioma:
En
Revista:
J Pharm Biomed Anal
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Malásia