Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets.
J Pharm Biomed Anal
; 44(5): 1064-71, 2007 Sep 03.
Article
en En
| MEDLINE
| ID: mdl-17560750
ABSTRACT
A dissolution method with high performance liquid chromatography (HPLC) analysis was validated for an immediate release low dose tablet formulation. The method was validated to meet requirements for a global regulatory filing and this validation included specificity, precision, linearity, accuracy and range. Validation of precision included an intermediate precision study using an experimental design in order to satisfy Japanese regulatory requirements. In addition, filter suitability, standard and sample solution stability and method robustness were demonstrated. A statistical design of experiments was used for the robustness evaluation of both the dissolution method and the HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pirrolidinas
/
Tetrahidronaftalenos
/
Química Farmacéutica
/
Cromatografía Líquida de Alta Presión
/
Tecnología Farmacéutica
/
Moduladores de los Receptores de Estrógeno
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2007
Tipo del documento:
Article
País de afiliación:
Estados Unidos