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| 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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| Pandey,Saurabh; Pandey,Preeti; Kumar,Raj; Singh,Narendra Pal. |
| Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space. Based on good manufacturing practices, measuring residual solvents is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents (methanol, acetone, cyclohexane, dichloromethane, toluene) in Omeprazole, an active pharmaceutical ingredient was investigated. Omeprazole is a potent reversible inhibitor of the gastric proton pump H+/K+-ATPase. The Head space gas chromatography (HSGC) method described in this investigation utilized a SPB TM-624, Supelco, 30 m long x 0.25 mm internal diameter, 1.4µm-thick column. Since Omeprazole is a thermally labile compound, the selection of the proper injector... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Headspace-gas chromatography; Omeprazole; Method validation; Residual solvents release testing. |
| Ano: 2011 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200019 |
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