Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement

This study demonstrated that near infrared chemical imaging (NIR-CI) was a rapid and nondestructive technique for discrimination of chlorpheniramine maleate (CPM) and assessment of its surface content uniformity (SCU) in a pharmaceutical formulation. The characteristic wavenumber method was used for...

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Main Authors: Luwei Zhou, Zhisheng Wu, Xinyuan Shi, Manfei Xu, Xiaona Liu, Bing Xu, Yanjiang Qiao
Format: Article
Language:English
Published: Wiley 2014-01-01
Series:Journal of Spectroscopy
Online Access:http://dx.doi.org/10.1155/2014/741246
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author Luwei Zhou
Zhisheng Wu
Xinyuan Shi
Manfei Xu
Xiaona Liu
Bing Xu
Yanjiang Qiao
author_facet Luwei Zhou
Zhisheng Wu
Xinyuan Shi
Manfei Xu
Xiaona Liu
Bing Xu
Yanjiang Qiao
author_sort Luwei Zhou
collection DOAJ
description This study demonstrated that near infrared chemical imaging (NIR-CI) was a rapid and nondestructive technique for discrimination of chlorpheniramine maleate (CPM) and assessment of its surface content uniformity (SCU) in a pharmaceutical formulation. The characteristic wavenumber method was used for discriminating CPM distribution on the tablet surface. To assess the surface content uniformity of CPM, binary image and statistical measurement were proposed. Furthermore, high-performance liquid chromatography (HPLC) was used as reference method for accurately determining volume content of CPM in the sample. Moreover, HPLC was performed to assess volume content uniformity (VCU) of CPM in whole region and part region of the tablets. The NIR-CI result showed that the spatial distribution of CPM was heterogeneous on the tablet surface. Through the comparison of content uniformity of CPM determined by NIR-CI and HPLC, respectively, it demonstrated that a high degree of VCU did not imply a high degree of SCU of the samples. These results indicate that HPLC method is not suitable for testing SCU, and this has been verified by NIR-CI. This study proves the feasibility of NIR-CI for rapid discrimination of CPM and assessment of its SCU, which is helpful for the quality control of commercial CPM tablets.
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institution Kabale University
issn 2314-4920
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language English
publishDate 2014-01-01
publisher Wiley
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series Journal of Spectroscopy
spelling doaj-art-0319c8edec17451c9612191930e2fd5f2025-02-03T06:41:59ZengWileyJournal of Spectroscopy2314-49202314-49392014-01-01201410.1155/2014/741246741246Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical MeasurementLuwei Zhou0Zhisheng Wu1Xinyuan Shi2Manfei Xu3Xiaona Liu4Bing Xu5Yanjiang Qiao6Beijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaBeijing University of Chinese Medicine, Beijing 100102, ChinaThis study demonstrated that near infrared chemical imaging (NIR-CI) was a rapid and nondestructive technique for discrimination of chlorpheniramine maleate (CPM) and assessment of its surface content uniformity (SCU) in a pharmaceutical formulation. The characteristic wavenumber method was used for discriminating CPM distribution on the tablet surface. To assess the surface content uniformity of CPM, binary image and statistical measurement were proposed. Furthermore, high-performance liquid chromatography (HPLC) was used as reference method for accurately determining volume content of CPM in the sample. Moreover, HPLC was performed to assess volume content uniformity (VCU) of CPM in whole region and part region of the tablets. The NIR-CI result showed that the spatial distribution of CPM was heterogeneous on the tablet surface. Through the comparison of content uniformity of CPM determined by NIR-CI and HPLC, respectively, it demonstrated that a high degree of VCU did not imply a high degree of SCU of the samples. These results indicate that HPLC method is not suitable for testing SCU, and this has been verified by NIR-CI. This study proves the feasibility of NIR-CI for rapid discrimination of CPM and assessment of its SCU, which is helpful for the quality control of commercial CPM tablets.http://dx.doi.org/10.1155/2014/741246
spellingShingle Luwei Zhou
Zhisheng Wu
Xinyuan Shi
Manfei Xu
Xiaona Liu
Bing Xu
Yanjiang Qiao
Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
Journal of Spectroscopy
title Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
title_full Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
title_fullStr Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
title_full_unstemmed Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
title_short Rapid Discrimination of Chlorpheniramine Maleate and Assessment of Its Surface Content Uniformity in a Pharmaceutical Formulation by NIR-CI Coupled with Statistical Measurement
title_sort rapid discrimination of chlorpheniramine maleate and assessment of its surface content uniformity in a pharmaceutical formulation by nir ci coupled with statistical measurement
url http://dx.doi.org/10.1155/2014/741246
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