This study aimed to develop and validate a reliable reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous separation and quantification of iomeprol and its related impurities in contrast agent injections. The method employed a Nanochrom ChromCore AQ C18 column with gradient elution using a mobile phase consisting of phosphate buffer and a mixture of water, acetonitrile, and 2-butanol. Through systematic optimization, the method effectively addressed the limitations of existing techniques, such as LC-MS/MS and online SPE-POPLC, including insufficient impurity resolution and high detection costs. Validated in accordance with ICH Q2(R1) guidelines, the method demonstrated excellent performance in all parameters: high specificity with baseline separation of all impurities and no interference from excipients; linearity over the range from LOQ to 200% (R² > 0.999); accuracy with recovery rates of 96%–101% (RSD < 3%); precision with RSD values below 2.0% for both repeatability and intermediate precision; and robustness under varied chromatographic conditions, with solutions remaining stable for up to 35 h. Forced degradation studies revealed that iomeprol is particularly susceptible to degradation under alkaline and photolytic conditions, highlighting the importance of pH control and light protection during formulation and storage. This RP-HPLC method provides a sensitive, accurate, precise, and robust analytical tool for quality control of iomeprol in both active pharmaceutical ingredients and finished products, offering significant technical support for enhancing drug quality and ensuring clinical medication safety.
Lou et al. (Fri,) studied this question.
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