Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry
Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmac...
Ausführliche Beschreibung
Autor*in: |
Abdelwahab, Nada S. [verfasserIn] |
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Format: |
Artikel |
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Sprache: |
Englisch |
Erschienen: |
2016 |
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Anmerkung: |
© Akadémiai Kiadó 2016 |
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Übergeordnetes Werk: |
Enthalten in: Journal of planar chromatography, modern TLC - Springer International Publishing, 1988, 29(2016), 6 vom: 01. Dez., Seite 462-468 |
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Übergeordnetes Werk: |
volume:29 ; year:2016 ; number:6 ; day:01 ; month:12 ; pages:462-468 |
Links: |
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DOI / URN: |
10.1556/1006.2016.29.6.9 |
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Katalog-ID: |
OLC2051473714 |
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520 | |a Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. | ||
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10.1556/1006.2016.29.6.9 doi (DE-627)OLC2051473714 (DE-He213)1006.2016.29.6.9-p DE-627 ger DE-627 rakwb eng 540 530 VZ Abdelwahab, Nada S. verfasserin aut Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry 2016 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © Akadémiai Kiadó 2016 Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. Elsaady, Mohammed T. aut Korany, Aml G. aut Hgazy, Maha A. aut Enthalten in Journal of planar chromatography, modern TLC Springer International Publishing, 1988 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)129250651 (DE-600)59576-7 (DE-576)017944201 0933-4173 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-PHY SSG-OLC-CHE GBV_ILN_31 GBV_ILN_70 GBV_ILN_2129 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)OLC2051473714 (DE-He213)1006.2016.29.6.9-p DE-627 ger DE-627 rakwb eng 540 530 VZ Abdelwahab, Nada S. verfasserin aut Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry 2016 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © Akadémiai Kiadó 2016 Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. Elsaady, Mohammed T. aut Korany, Aml G. aut Hgazy, Maha A. aut Enthalten in Journal of planar chromatography, modern TLC Springer International Publishing, 1988 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)129250651 (DE-600)59576-7 (DE-576)017944201 0933-4173 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-PHY SSG-OLC-CHE GBV_ILN_31 GBV_ILN_70 GBV_ILN_2129 AR 29 2016 6 01 12 462-468 |
allfields_unstemmed |
10.1556/1006.2016.29.6.9 doi (DE-627)OLC2051473714 (DE-He213)1006.2016.29.6.9-p DE-627 ger DE-627 rakwb eng 540 530 VZ Abdelwahab, Nada S. verfasserin aut Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry 2016 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © Akadémiai Kiadó 2016 Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. Elsaady, Mohammed T. aut Korany, Aml G. aut Hgazy, Maha A. aut Enthalten in Journal of planar chromatography, modern TLC Springer International Publishing, 1988 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)129250651 (DE-600)59576-7 (DE-576)017944201 0933-4173 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-PHY SSG-OLC-CHE GBV_ILN_31 GBV_ILN_70 GBV_ILN_2129 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)OLC2051473714 (DE-He213)1006.2016.29.6.9-p DE-627 ger DE-627 rakwb eng 540 530 VZ Abdelwahab, Nada S. verfasserin aut Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry 2016 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © Akadémiai Kiadó 2016 Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. Elsaady, Mohammed T. aut Korany, Aml G. aut Hgazy, Maha A. aut Enthalten in Journal of planar chromatography, modern TLC Springer International Publishing, 1988 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)129250651 (DE-600)59576-7 (DE-576)017944201 0933-4173 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-PHY SSG-OLC-CHE GBV_ILN_31 GBV_ILN_70 GBV_ILN_2129 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)OLC2051473714 (DE-He213)1006.2016.29.6.9-p DE-627 ger DE-627 rakwb eng 540 530 VZ Abdelwahab, Nada S. verfasserin aut Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry 2016 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © Akadémiai Kiadó 2016 Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. Elsaady, Mohammed T. aut Korany, Aml G. aut Hgazy, Maha A. aut Enthalten in Journal of planar chromatography, modern TLC Springer International Publishing, 1988 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)129250651 (DE-600)59576-7 (DE-576)017944201 0933-4173 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-PHY SSG-OLC-CHE GBV_ILN_31 GBV_ILN_70 GBV_ILN_2129 AR 29 2016 6 01 12 462-468 |
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Abdelwahab, Nada S. |
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10.1556/1006.2016.29.6.9 |
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540 530 |
title_sort |
determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
title_auth |
Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
abstract |
Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. © Akadémiai Kiadó 2016 |
abstractGer |
Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. © Akadémiai Kiadó 2016 |
abstract_unstemmed |
Summary Dantrolene sodium (DAN) is widely used as a muscle relaxant drug for the treatment of malignant hyperthermia. 5-(4-Nitrophenyl)-2-furaldehyde is reported to be DAN-related compound C (DC), and it is the synthetic precursor of DAN that may be presented as process-related impurity in a pharmaceutical formulation. Also, it is considered to be the acidic and photolytic degradation product of DAN. The synthesis of DC has been performed from p-nitroaniline with good yield and high purity; structure elucidation has been confirmed by infrared (IR), mass spectrometry (MS), and nuclear magnetic resonance (NMR) analyses. In the present study, high-performance thin-layer chromatography (HPTLC) technique was developed and validated for the separation and quantification of DAN along with DC. Separation was carried out on HPTLC silica gel 60 $ F_{254} $ plates using a developing system consisting of chloroform—ethylacetate—acetic acid (10:0.5:0.01, by volume) with ultraviolet (UV) scanning at 380 nm. The method was highly sensitive and could be used for the determination of DAN and DC in the range of 0.1–1.5 μg $ band^{−1} $ and 0.1–2.0 μg $ band^{−1} $, respectively. The method has been validated in compliance with the International Conference on Harmonization (ICH) guidelines and was successfully applied to a pharmaceutical formulation. The method was compared favorably with the reported British Pharmacopoeia high-performance liquid chromatography (BP HPLC) method. © Akadémiai Kiadó 2016 |
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container_issue |
6 |
title_short |
Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
url |
https://doi.org/10.1556/1006.2016.29.6.9 |
remote_bool |
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author2 |
Elsaady, Mohammed T. Korany, Aml G. Hgazy, Maha A. |
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up_date |
2024-07-04T04:31:43.168Z |
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