Quantitative determination and validation of octreotide acetate using 1 H-NMR spectroscopy with internal standard method

Copyright © 2017 John Wiley & Sons, Ltd.

Bibliographische Detailangaben
Veröffentlicht in:Magnetic resonance in chemistry : MRC. - 1985. - 56(2018), 1 vom: 27. Jan., Seite 37-45
1. Verfasser: Yu, Chen (VerfasserIn)
Weitere Verfasser: Zhang, Qian, Xu, Peng-Yao, Bai, Yin, Shen, Wen-Bin, Di, Bin, Su, Meng-Xiang
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2018
Zugriff auf das übergeordnete Werk:Magnetic resonance in chemistry : MRC
Schlagworte:Journal Article 1H assay gemcitabine hydrochloride octreotide acetate peptide drugs quantitative nuclear magnetic resonance Deuterium Oxide J65BV539M3 Octreotide RWM8CCW8GP
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520 |a Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated 1 H-qNMR method for assay of octreotide acetate, a kind of cyclic octopeptide. Deuterium oxide was used to remove the undesired exchangeable peaks, which was referred to as proton exchange, in order to make the quantitative signals isolated in the crowded spectrum of the peptide and ensure precise quantitative analysis. Gemcitabine hydrochloride was chosen as the suitable internal standard. Experimental conditions, including relaxation delay time, the numbers of scans, and pulse angle, were optimized first. Then method validation was carried out in terms of selectivity, stability, linearity, precision, and robustness. The assay result was compared with that by means of high performance liquid chromatography, which is provided by Chinese Pharmacopoeia. The statistical F test, Student's t test, and nonparametric test at 95% confidence level indicate that there was no significant difference between these two methods. qNMR is a simple and accurate quantitative tool with no need for specific corresponding reference standards. It has the potential of the quantitative analysis of other peptide drugs and standardization of the corresponding reference standards 
650 4 |a Journal Article 
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650 4 |a gemcitabine hydrochloride 
650 4 |a octreotide acetate 
650 4 |a peptide drugs 
650 4 |a quantitative nuclear magnetic resonance 
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650 7 |a J65BV539M3  |2 NLM 
650 7 |a Octreotide  |2 NLM 
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700 1 |a Zhang, Qian  |e verfasserin  |4 aut 
700 1 |a Xu, Peng-Yao  |e verfasserin  |4 aut 
700 1 |a Bai, Yin  |e verfasserin  |4 aut 
700 1 |a Shen, Wen-Bin  |e verfasserin  |4 aut 
700 1 |a Di, Bin  |e verfasserin  |4 aut 
700 1 |a Su, Meng-Xiang  |e verfasserin  |4 aut 
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