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Development and validation of an HPLC method for stability evaluation of nystatin BJPS
Cione,Ana Paola Prata; Liberale,Márcio José; Silva,Paulo Marcos da.
A liquid chromatography method for evaluating the stability of Nystatin (Nys) in an ointment was developed and validated, since the traditional pharmacopeial microbiological methods are unable to indicate stability. The stress experiments showed that Nys was found to significantly degrade in alkaline and acidic conditions and also under oxidative stress. Lower levels of degradation were detected under heat and with the sample exposed to Xenon light. Resolutions higher than 2 for Nys and degradation products (DP) chromatographic peaks were achieved by using an Inerstil ODS-3 column, isocratic elution with methanol:water and UV detection at 305 nm. The system was found to be linear over a range of 102 to 310 IU mL-1 and proved precise, since the RSD(%) was...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Nystatin/stability analysis; Forced degradation/stress; High performance liquid chromatography/qualitative analysis.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000200018
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