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...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Published: |
Wiley-VCH Verlag
2017
|
| Subjects: | |
| Online Access: | http://eprints.utm.my/id/eprint/76548/ https://www.scopus.com/inward/record.uri?eid=2-s2.0-85021423151&doi=10.1002%2fjssc.201700252&partnerID=40&md5=16e559685ca8cc509cf5c666ce8bdebb |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| id |
my.utm.76548 |
|---|---|
| record_format |
eprints |
| spelling |
my.utm.765482018-04-30T13:30:48Z http://eprints.utm.my/id/eprint/76548/ 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. Abdul Majid, Z. 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. and Abdul Majid, Z. (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 https://www.scopus.com/inward/record.uri?eid=2-s2.0-85021423151&doi=10.1002%2fjssc.201700252&partnerID=40&md5=16e559685ca8cc509cf5c666ce8bdebb 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. Abdul Majid, Z. 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. Abdul Majid, Z. |
| author_facet |
Reddy, A. V. B. Yusop, Z. Jaafar, J. Aris, A. Abdul Majid, Z. |
| 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/76548/ https://www.scopus.com/inward/record.uri?eid=2-s2.0-85021423151&doi=10.1002%2fjssc.201700252&partnerID=40&md5=16e559685ca8cc509cf5c666ce8bdebb |
| _version_ |
1643657341580607488 |
| score |
13.223943 |