Data/hora: 05/06/2024 10:10:25

Provedor de dados: | 60
País: | Brazil
Título: | A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations
Autores: | Pandey,Saurabh; Pandey,Preeti; Mishra,Durgesh; Singh,Umesh Kumar.
Data: | 2013-03-01
Ano: | 2013
Palavras-chave: | High performance liquid chromatography/qualitative analysis; High performance liquid chromatography/method development; Pantoprazole/forced degradation.
Resumo: | A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 µgmL-1), LOQ (0.13-0.14 µgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100019
Editor: | Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação: | 10.1590/S1984-82502013000100019
Formato: | text/html
Fonte: | Brazilian Journal of Pharmaceutical Sciences  v.49 n.1 2013
Fonte: | info:eu-repo/semantics/openAccess