A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations

An extremely sensitive and simple gas chromatography with mass spectrometry method was developed and completely validated for the analysis of five process-related impurities, viz., 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, 4-hydroxyphenylacetic acid, methyl-4-hydroxyphenylacetate, and...

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Main Authors: Reddy, A. V. B., Yusop, Z., Jaafar, J., Aris, A.
Format: Article
Published: Wiley VCH Verlag 2017
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Online Access:http://eprints.utm.my/id/eprint/80989/
http://dx.doi.org/10.1002/jssc.201700252
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spelling my.utm.809892019-07-24T03:34:29Z http://eprints.utm.my/id/eprint/80989/ A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations Reddy, A. V. B. Yusop, Z. Jaafar, J. Aris, A. QD Chemistry An extremely sensitive and simple gas chromatography with mass spectrometry method was developed and completely validated for the analysis of five process-related impurities, viz., 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, 4-hydroxyphenylacetic acid, methyl-4-hydroxyphenylacetate, and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile, in atenolol. The separation of impurities was accomplished on a BPX-5 column with dimensions of 50 m × 0.25 mm i.d. and 0.25 μm film thickness. The method validation was performed following International Conference on Harmonisation guidelines in which the method was capable to quantitate 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid at 0.3 ppm, and methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile at 0.35 ppm with respect to 10 mg/mL of atenolol. The method was linear over the concentration range of 0.3–10 ppm for 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid, and 0.35–10 ppm for methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile. The correlation coefficient in each case was found ≥0.998. The repeatability and recovery values were acceptable, and found between 89.38% and 105.60% for all five impurities under optimized operating conditions. The method developed here is simple, selective, and sensitive with apparently better resolution than the reported methods. Hence, the method is a straightforward and good quality control tool for the quantitation of selected impurities at trace concentrations in atenolol. Wiley VCH Verlag 2017 Article PeerReviewed Reddy, A. V. B. and Yusop, Z. and Jaafar, J. and Aris, A. (2017) A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations. Journal of Separation Science, 40 (15). pp. 3086-3093. ISSN 1615-9306 http://dx.doi.org/10.1002/jssc.201700252 DOI:10.1002/jssc.201700252
institution Universiti Teknologi Malaysia
building UTM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Teknologi Malaysia
content_source UTM Institutional Repository
url_provider http://eprints.utm.my/
topic QD Chemistry
spellingShingle QD Chemistry
Reddy, A. V. B.
Yusop, Z.
Jaafar, J.
Aris, A.
A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
description An extremely sensitive and simple gas chromatography with mass spectrometry method was developed and completely validated for the analysis of five process-related impurities, viz., 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, 4-hydroxyphenylacetic acid, methyl-4-hydroxyphenylacetate, and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile, in atenolol. The separation of impurities was accomplished on a BPX-5 column with dimensions of 50 m × 0.25 mm i.d. and 0.25 μm film thickness. The method validation was performed following International Conference on Harmonisation guidelines in which the method was capable to quantitate 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid at 0.3 ppm, and methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile at 0.35 ppm with respect to 10 mg/mL of atenolol. The method was linear over the concentration range of 0.3–10 ppm for 4-hydroxy-l-phenylglycine, 4-hydroxyphenylacetonitrile, and 4-hydroxyphenylacetic acid, and 0.35–10 ppm for methyl-4-hydroxyphenylacetate and 2-[4-{(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy}phenyl]acetonitrile. The correlation coefficient in each case was found ≥0.998. The repeatability and recovery values were acceptable, and found between 89.38% and 105.60% for all five impurities under optimized operating conditions. The method developed here is simple, selective, and sensitive with apparently better resolution than the reported methods. Hence, the method is a straightforward and good quality control tool for the quantitation of selected impurities at trace concentrations in atenolol.
format Article
author Reddy, A. V. B.
Yusop, Z.
Jaafar, J.
Aris, A.
author_facet Reddy, A. V. B.
Yusop, Z.
Jaafar, J.
Aris, A.
author_sort Reddy, A. V. B.
title A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
title_short A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
title_full A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
title_fullStr A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
title_full_unstemmed A simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
title_sort simple, selective, and sensitive gas chromatography mass spectrometry method for the analysis of five process related impurities in atenolol bulk drug and capsule formulations
publisher Wiley VCH Verlag
publishDate 2017
url http://eprints.utm.my/id/eprint/80989/
http://dx.doi.org/10.1002/jssc.201700252
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