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

• 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.

Nuclear magnetic resonance spectroscopy was used for direct quantitative determination of iobitridol in an injectable formulation. The method was developed on a medium field strength magnet (400 MHz) and validation was performed by assessing specificity, accuracy, precision, linearity, stability of samples and robustness. Validation data confirm that the method is highly appropriate for direct quantification of iobitridol in the final formulation. Moreover the method has a good potential for rapid screening analyses due to straightforward experimental setup and lack of any sample pretreatment.

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