Quantitative analysis of iobitridol in an injectable preparation by 1H NMR spectroscopy.

Journal of Pharmaceutical and Biomedical Analysis(2014)

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摘要
•A qNMR method was used for direct assay determination of iobitridol in an injectable formulation.•Experiments were carried out in deuterated alkaline water with 3,5-dinitrobenzoic acid as internal reference standard.•Method was validated by assessing specificity, accuracy, precision, linearity, stability of samples and robustness.•Method proved suitable for routine controls especially when high sample throughput is required.
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关键词
qNMR,iobitridol,validation,quality control,assay determination
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