Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method

A selective, precise and stability-indicating, modified high performance liquid chromatographic method for the analysis of sodium picosulfate both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation product, it can be...

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Main Authors: IVANA SAVIĆ, GORAN NIKOLIĆ, VALENTINA MARINKOVIĆ, IVAN SAVIĆ
Format: Article
Language:English
Published: Association of the Chemical Engineers of Serbia 2010-03-01
Series:Chemical Industry and Chemical Engineering Quarterly
Subjects:
Online Access:http://www.ache.org.rs/CICEQ/2010/No1/CICEQ_Vol16_%20No1_pp103-110_Jan-Mar_2010.pdf
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author IVANA SAVIĆ
GORAN NIKOLIĆ
VALENTINA MARINKOVIĆ
IVAN SAVIĆ
author_facet IVANA SAVIĆ
GORAN NIKOLIĆ
VALENTINA MARINKOVIĆ
IVAN SAVIĆ
author_sort IVANA SAVIĆ
collection DOAJ
description A selective, precise and stability-indicating, modified high performance liquid chromatographic method for the analysis of sodium picosulfate both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one. The chromatographic separation was achieved on a ZORBAX Eclipse XDB C-18 analytical column. The mobile phase consisted of phosphate buffer (pH 7):acetonitrile (85:15 v/v). The absorbance was monitored with a DAD detector at 263 nm. The flow rate was 1.5 mL min-1. Statistical analysis proved the method is repeatable, selective, and accurate for estimation of sodium picosulfate in the presence its degradation product. Forced degradation studies were performed on bulk sample of sodium picosulfate using heat (25, 40, 60 and 80 °C) and oxidation (0.1, 0.5 and 1% v/v hydrogen peroxide). The proposed method was successfully applied, with excellent recovery, to the analysis of a pharmaceutical formulation (Sodium picosulfate, Zdravlje-Actavis, Serbia)
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spelling doaj.art-f1bf573450e8462690a578fcb885c6e92022-12-22T02:45:06ZengAssociation of the Chemical Engineers of SerbiaChemical Industry and Chemical Engineering Quarterly1451-93722010-03-01161103110Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC methodIVANA SAVIĆGORAN NIKOLIĆVALENTINA MARINKOVIĆIVAN SAVIĆA selective, precise and stability-indicating, modified high performance liquid chromatographic method for the analysis of sodium picosulfate both as a bulk drug and in formulations was developed and validated. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one. The chromatographic separation was achieved on a ZORBAX Eclipse XDB C-18 analytical column. The mobile phase consisted of phosphate buffer (pH 7):acetonitrile (85:15 v/v). The absorbance was monitored with a DAD detector at 263 nm. The flow rate was 1.5 mL min-1. Statistical analysis proved the method is repeatable, selective, and accurate for estimation of sodium picosulfate in the presence its degradation product. Forced degradation studies were performed on bulk sample of sodium picosulfate using heat (25, 40, 60 and 80 °C) and oxidation (0.1, 0.5 and 1% v/v hydrogen peroxide). The proposed method was successfully applied, with excellent recovery, to the analysis of a pharmaceutical formulation (Sodium picosulfate, Zdravlje-Actavis, Serbia)http://www.ache.org.rs/CICEQ/2010/No1/CICEQ_Vol16_%20No1_pp103-110_Jan-Mar_2010.pdfsodium picosulfatedegradationRP-HPLCstabilitykinetic
spellingShingle IVANA SAVIĆ
GORAN NIKOLIĆ
VALENTINA MARINKOVIĆ
IVAN SAVIĆ
Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
Chemical Industry and Chemical Engineering Quarterly
sodium picosulfate
degradation
RP-HPLC
stability
kinetic
title Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
title_full Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
title_fullStr Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
title_full_unstemmed Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
title_short Monitoring of thermal and oxidation stability of sodium picosulfate by modified RP-HPLC method
title_sort monitoring of thermal and oxidation stability of sodium picosulfate by modified rp hplc method
topic sodium picosulfate
degradation
RP-HPLC
stability
kinetic
url http://www.ache.org.rs/CICEQ/2010/No1/CICEQ_Vol16_%20No1_pp103-110_Jan-Mar_2010.pdf
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AT valentinamarinkovic monitoringofthermalandoxidationstabilityofsodiumpicosulfatebymodifiedrphplcmethod
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