Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets

In the present study an isocratic reversed-phase high-performance liquid chromatography method was developed for the estimation of zolpidem in bulk drug and pharmaceutical dosage forms. The quantification was carried out on C18 columns. A mixture of acetonitrile-ammonium acetate (pH=8.0, 0.02 M) (60...

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Main Authors: E. Konoz, A. H. Mohsen Sarrafi, R. Abdolahnejad, M. Bahrami-Zonoz
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2013/357890
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author E. Konoz
A. H. Mohsen Sarrafi
R. Abdolahnejad
M. Bahrami-Zonoz
author_facet E. Konoz
A. H. Mohsen Sarrafi
R. Abdolahnejad
M. Bahrami-Zonoz
author_sort E. Konoz
collection DOAJ
description In the present study an isocratic reversed-phase high-performance liquid chromatography method was developed for the estimation of zolpidem in bulk drug and pharmaceutical dosage forms. The quantification was carried out on C18 columns. A mixture of acetonitrile-ammonium acetate (pH=8.0, 0.02 M) (60 : 40 v/v) was used as the mobile phase, at flow rate of 1.0 mL/min and the determination wavelength at 245 nm. The retention time of zolpidem was found to be 3–5 min. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness. The linear dynamic range was from 2.5 to 30 μg mL−1. Regression equation was found to be y=0.1416x+0.0183 with correlation coefficient r=0.9996. The percentage recovery obtained for zolpidem was greater than 96.5%. Limit of quantification and limit of detection were found to be 2.5 μg mL−1 and 0.83 μg mL−1, respectively. The developed method can be used for routine quality control analysis of zolpidem in tablet formulations.
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institution Kabale University
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series Journal of Chemistry
spelling doaj-art-7946958a1c2f4fc983c97dc4bf758c702025-02-03T01:04:58ZengWileyJournal of Chemistry2090-90632090-90712013-01-01201310.1155/2013/357890357890Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and TabletsE. Konoz0A. H. Mohsen Sarrafi1R. Abdolahnejad2M. Bahrami-Zonoz3Department of Chemistry, Islamic Azad University, Central Tehran Branch, Tehran 13185-768, IranDepartment of Chemistry, Islamic Azad University, Central Tehran Branch, Tehran 13185-768, IranLoghman Pharmaceutical Co., P.O. Box 14155, Tehran 1443, IranDepartment of Chemistry, Islamic Azad University, Central Tehran Branch, Tehran 13185-768, IranIn the present study an isocratic reversed-phase high-performance liquid chromatography method was developed for the estimation of zolpidem in bulk drug and pharmaceutical dosage forms. The quantification was carried out on C18 columns. A mixture of acetonitrile-ammonium acetate (pH=8.0, 0.02 M) (60 : 40 v/v) was used as the mobile phase, at flow rate of 1.0 mL/min and the determination wavelength at 245 nm. The retention time of zolpidem was found to be 3–5 min. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness. The linear dynamic range was from 2.5 to 30 μg mL−1. Regression equation was found to be y=0.1416x+0.0183 with correlation coefficient r=0.9996. The percentage recovery obtained for zolpidem was greater than 96.5%. Limit of quantification and limit of detection were found to be 2.5 μg mL−1 and 0.83 μg mL−1, respectively. The developed method can be used for routine quality control analysis of zolpidem in tablet formulations.http://dx.doi.org/10.1155/2013/357890
spellingShingle E. Konoz
A. H. Mohsen Sarrafi
R. Abdolahnejad
M. Bahrami-Zonoz
Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
Journal of Chemistry
title Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
title_full Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
title_fullStr Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
title_full_unstemmed Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
title_short Development and Validation of a Reversed-Phase HPLC Method for the Estimation of Zolpidem in Bulk Drug and Tablets
title_sort development and validation of a reversed phase hplc method for the estimation of zolpidem in bulk drug and tablets
url http://dx.doi.org/10.1155/2013/357890
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AT rabdolahnejad developmentandvalidationofareversedphasehplcmethodfortheestimationofzolpideminbulkdrugandtablets
AT mbahramizonoz developmentandvalidationofareversedphasehplcmethodfortheestimationofzolpideminbulkdrugandtablets