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
Gespeichert in:
| Autor*in: |
Abdelwahab, Nada S. [verfasserIn] Elsaady, Mohammed T. [verfasserIn] Korany, Aml G. [verfasserIn] Hgazy, Maha A. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2016 |
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| Übergeordnetes Werk: |
Enthalten in: Journal of planar chromatography, modern TLC - Budapest : Akadémiai Kiadó, 2001, 29(2016), 6 vom: 01. Dez., Seite 462-468 |
|---|---|
| Übergeordnetes Werk: |
volume:29 ; year:2016 ; number:6 ; day:01 ; month:12 ; pages:462-468 |
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| DOI / URN: |
10.1556/1006.2016.29.6.9 |
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SPR039176738 |
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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)SPR039176738 (SPR)1006.2016.29.6.9-e DE-627 ger DE-627 rakwb eng 540 530 ASE 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 Computermedien c rdamedia Online-Ressource cr rdacarrier 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. verfasserin aut Korany, Aml G. verfasserin aut Hgazy, Maha A. verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://dx.doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_22 GBV_ILN_31 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2129 GBV_ILN_2190 GBV_ILN_4305 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)SPR039176738 (SPR)1006.2016.29.6.9-e DE-627 ger DE-627 rakwb eng 540 530 ASE 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 Computermedien c rdamedia Online-Ressource cr rdacarrier 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. verfasserin aut Korany, Aml G. verfasserin aut Hgazy, Maha A. verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://dx.doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_22 GBV_ILN_31 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2129 GBV_ILN_2190 GBV_ILN_4305 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)SPR039176738 (SPR)1006.2016.29.6.9-e DE-627 ger DE-627 rakwb eng 540 530 ASE 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 Computermedien c rdamedia Online-Ressource cr rdacarrier 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. verfasserin aut Korany, Aml G. verfasserin aut Hgazy, Maha A. verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://dx.doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_22 GBV_ILN_31 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2129 GBV_ILN_2190 GBV_ILN_4305 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)SPR039176738 (SPR)1006.2016.29.6.9-e DE-627 ger DE-627 rakwb eng 540 530 ASE 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 Computermedien c rdamedia Online-Ressource cr rdacarrier 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. verfasserin aut Korany, Aml G. verfasserin aut Hgazy, Maha A. verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://dx.doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_22 GBV_ILN_31 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2129 GBV_ILN_2190 GBV_ILN_4305 AR 29 2016 6 01 12 462-468 |
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10.1556/1006.2016.29.6.9 doi (DE-627)SPR039176738 (SPR)1006.2016.29.6.9-e DE-627 ger DE-627 rakwb eng 540 530 ASE 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 Computermedien c rdamedia Online-Ressource cr rdacarrier 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. verfasserin aut Korany, Aml G. verfasserin aut Hgazy, Maha A. verfasserin aut Enthalten in Journal of planar chromatography, modern TLC Budapest : Akadémiai Kiadó, 2001 29(2016), 6 vom: 01. Dez., Seite 462-468 (DE-627)529764563 (DE-600)2304198-5 1789-0993 nnns volume:29 year:2016 number:6 day:01 month:12 pages:462-468 https://dx.doi.org/10.1556/1006.2016.29.6.9 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_22 GBV_ILN_31 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2129 GBV_ILN_2190 GBV_ILN_4305 AR 29 2016 6 01 12 462-468 |
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Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
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Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
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Abdelwahab, Nada S. |
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Journal of planar chromatography, modern TLC |
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Abdelwahab, Nada S. Elsaady, Mohammed T. Korany, Aml G. Hgazy, Maha A. |
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Elektronische Aufsätze |
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determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
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Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
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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. |
| 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. |
| 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. |
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Determination of dantrolene sodium in the presence of its process-related impurity by high-performance thin-layer chromatography—spectrodensitometry |
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