Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method
AUTOR(ES)
Diego, Marta de, Godoy, Gloria, Mennickent, Sigrid, Godoy, Ricardo
FONTE
Química Nova
DATA DE PUBLICAÇÃO
2011
RESUMO
The chemical stability of enalapril drug substance and tablets was studied by a stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under various conditions. Accelerated stability testing was carried out for different formulations of enalapril tablets. Chromatographic separation was achieved on a RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1 and UV detection. Degradation of the drug substance was greater under hydrolytic conditions. After 180 days of accelerated stability testing most enalapril tablets showed more than 10% of degradation. Enalapril drug substance and tablets showed instability under stress and accelerated testing respectively, with possible implications on the therapeutic activity.
Documentos Relacionados
- Stability-indicating liquid chromatographic and UV spectrophotometric methods for the quantification of ciprofibrate in capsules and tablets
- Stability-indicating capillary zone electrophoresis assay for the analysis of linezolid in tablets
- Citalopram Hydrobromide: degradation product characterization and a validated stability-indicating LC-UV method
- Stability-indicating RP-LC method for quantification of fusidic acid in cream
- Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form