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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Format: | Article |
Language: | English |
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Association of the Chemical Engineers of Serbia
2010-03-01
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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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id | doaj.art-f1bf573450e8462690a578fcb885c6e9 |
institution | Directory Open Access Journal |
issn | 1451-9372 |
language | English |
last_indexed | 2024-04-13T13:27:43Z |
publishDate | 2010-03-01 |
publisher | Association of the Chemical Engineers of Serbia |
record_format | Article |
series | Chemical Industry and Chemical Engineering Quarterly |
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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