RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug

A reverse phase HPLC method is described for the determination of cinitapride hydrogen tartrate in the presence of its degradation products in bulk drug. A drug was subjected to all stress conditions such as reduction, oxidation acidic and alkaline medium. Chromatography was recorded on an Intersil...

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Main Authors: S. M. N. Roy, Kiran V. Mangaonkar, A. Y. Desai, Santosh M. Yetal
Format: Article
Language:English
Published: Wiley 2010-01-01
Series:E-Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2010/259507
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author S. M. N. Roy
Kiran V. Mangaonkar
A. Y. Desai
Santosh M. Yetal
author_facet S. M. N. Roy
Kiran V. Mangaonkar
A. Y. Desai
Santosh M. Yetal
author_sort S. M. N. Roy
collection DOAJ
description A reverse phase HPLC method is described for the determination of cinitapride hydrogen tartrate in the presence of its degradation products in bulk drug. A drug was subjected to all stress conditions such as reduction, oxidation acidic and alkaline medium. Chromatography was recorded on an Intersil ODS-3 column using mixture of acetonitrile and phosphate buffer, pH adjusted to 6.7 in the ratio (70:30 v/v) as the mobile phase at the rate of 1.0 mL/min with detection at 260 nm. Glimepride was used as internal standard. The retention time of drug cinitapride was 3.8 min and glimepride an internal standard was 2.5 minute. The drug was found to degrade extensively in reduction conditions and mild degradation in the presence of in alkaline, acidic and oxidative but the drug was stable in thermal stress. The method was validated by determining its specificity, linearity, precision and accuracy. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of cinitapride in the presence of its degradation products in the bulk drug. The proposed method is simple, fast, accurate and precise and hence applied for routine quality control of cinitapride in bulk drug. It can be used for analysis of samples during stability testing.
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spelling doaj-art-fe9382b8a28d4a2a83a3164fce0dc6752025-02-03T05:52:03ZengWileyE-Journal of Chemistry0973-49452090-98102010-01-017131131910.1155/2010/259507RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk DrugS. M. N. Roy0Kiran V. Mangaonkar1A. Y. Desai2Santosh M. Yetal3Mithibai College of Art, Chawhan Institute of Science, Amrutben Jivanlal College of Commerce and Economics, Vileparle(West), Mumbai-400056, IndiaMithibai College of Art, Chawhan Institute of Science, Amrutben Jivanlal College of Commerce and Economics, Vileparle(West), Mumbai-400056, IndiaMithibai College of Art, Chawhan Institute of Science, Amrutben Jivanlal College of Commerce and Economics, Vileparle(West), Mumbai-400056, IndiaMithibai College of Art, Chawhan Institute of Science, Amrutben Jivanlal College of Commerce and Economics, Vileparle(West), Mumbai-400056, IndiaA reverse phase HPLC method is described for the determination of cinitapride hydrogen tartrate in the presence of its degradation products in bulk drug. A drug was subjected to all stress conditions such as reduction, oxidation acidic and alkaline medium. Chromatography was recorded on an Intersil ODS-3 column using mixture of acetonitrile and phosphate buffer, pH adjusted to 6.7 in the ratio (70:30 v/v) as the mobile phase at the rate of 1.0 mL/min with detection at 260 nm. Glimepride was used as internal standard. The retention time of drug cinitapride was 3.8 min and glimepride an internal standard was 2.5 minute. The drug was found to degrade extensively in reduction conditions and mild degradation in the presence of in alkaline, acidic and oxidative but the drug was stable in thermal stress. The method was validated by determining its specificity, linearity, precision and accuracy. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of cinitapride in the presence of its degradation products in the bulk drug. The proposed method is simple, fast, accurate and precise and hence applied for routine quality control of cinitapride in bulk drug. It can be used for analysis of samples during stability testing.http://dx.doi.org/10.1155/2010/259507
spellingShingle S. M. N. Roy
Kiran V. Mangaonkar
A. Y. Desai
Santosh M. Yetal
RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
E-Journal of Chemistry
title RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
title_full RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
title_fullStr RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
title_full_unstemmed RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
title_short RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug
title_sort rp hplc method for the determination of cinitapride in the presence of its degradation products in bulk drug
url http://dx.doi.org/10.1155/2010/259507
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