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

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

Related Articles Quantitative determination and validation of octreotide acetate using (1) H-NMR spectroscopy with internal standard method.

Magn Reson Chem. 2017 Sep 15;:

Authors: Yu C, Zhang Q, Xu PY, Bai Y, Shen WB, Di B, Su MX

Abstract
Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated (1) H quantitative nuclear magnetic resonance ((1) H-qNMR) method for assay of octreotide acetate (OCT-Ac), 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 (IS). 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 (HPLC), which is provided by Chinese Pharmacopoeia. The statistical F test, student 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.


PMID: 28921691 [PubMed - as supplied by publisher]



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