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A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations BJPS
Pandey,Saurabh; Pandey,Preeti; Mishra,Durgesh; Singh,Umesh Kumar.
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,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: High performance liquid chromatography/qualitative analysis; High performance liquid chromatography/method development; Pantoprazole/forced degradation.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000100019
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