Validated column high-performance liquid chromatographic method for determination of aspirin and clopidogrel in combined tablets in the presence of degradation products formed under ICH-recommended stress conditions.
J AOAC Int
; 92(1): 152-7, 2009.
Article
en En
| MEDLINE
| ID: mdl-19382573
The development and validation of a column high-performance liquid chromatographic assay method for the determination of aspirin and clopidogrel in tablet formulation are described. The combination formulation was subjected to International Conference on Harmonization-recommended stress conditions. Separation of the drugs from the degradation products formed under stress conditions was achieved on an octasilyl (C8) column using 0.3% orthophosphoric acid-acetonitrile (65 + 35, v/v) mobile phase. The method was validated for specificity, linearity, limits of detection and quantification, precision, accuracy, and robustness. The method was found to be specific against placebo interference and during the forced degradation. The response was linear in the concentration range of 30.0-120.0 microg/mL for aspirin and 15.0-60.0 microg/mL for clopidogrel, with a correlation coefficient of 0.9999 for both. The relative standard deviation values for intra- and interday precision were <2.0%. The accuracy was between 99.12 and 99.83% for aspirin and 98.20 and 100.35% for clopidogrel. Stress testing showed degradation products that were well-separated from the parent compound, confirming the stability-indicating capacity of the method.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Comprimidos
/
Ticlopidina
/
Aspirina
/
Cromatografía Líquida de Alta Presión
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
J AOAC Int
Año:
2009
Tipo del documento:
Article
País de afiliación:
India
Pais de publicación:
Reino Unido