Evidence map›Paper›PMID 42151206›Full record

ArticleScientific reports2026

Development and validation of a stability-indicating high-performance liquid chromatography method for iomeprol.

Tingting Lou, Jiaqi He, Guoqing Wu, Luwei Wang, Hangyu Zhao, Yuchen Su, Yifu Kong, Huina Zhang, Yonghua Yu, Jie Gu

Abstract readValidation Study
In one paragraph

Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Tingting LouTongde Hospital of Zhejiang Province, Hangzhou, China.
Jiaqi HeTongde Hospital of Zhejiang Province, Hangzhou, China.
Guoqing WuTongde Hospital of Zhejiang Province, Hangzhou, China.
Luwei WangTongde Hospital of Zhejiang Province, Hangzhou, China.
Hangyu ZhaoFuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China.
Yuchen SuFuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China.
Yifu KongFuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China.
Huina ZhangFuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China.
Yonghua YuFuan Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd, Ningbo, China. y_hua23@163.com.
Jie GuDepartment of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. wwkso@zju.edu.cn.

Funding

The Basic Public Welfare Research Program of Zhejiang Province LGC22H280009Zhejiang Traditional Chinese Medicine Science and Technology Program 2022ZA033
6 · The paper itself

Abstract

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.

Indexed as

Drug StabilityIopamidolChromatography, High Pressure LiquidChromatography, Reverse-PhaseHydrogen-Ion ConcentrationReproducibility of ResultsTandem Mass SpectrometryiomeprolIopamidolContrast AgentHPLCIomeprolMethod Validation

Identifiers

PMID42151206
PMCPMC13184106

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