Effective Determination of Pharmaceutical Impurities by Two Dimensional Liquid Chromatography

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Zhimin Li, Paula Hong, and Patricia McConville
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Application Notes
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The analysis of pharmaceutical drugs and their impurities can be challenging, particularly when geometric isomer impurities are present. To address these challenges, a 2D integrated solution can enable both analyses to be performed on a single system setup. This allows for increased productivity with reliable quantitation for both separations.

The ACQUITY UPLC H-class Bio System with 2D technology featuring “Heartcut-ACD-Trap-Elute” addresses these challenges. This solution provides a RPLC separation in the 1st dimension to separate related compounds of API, and cis-isomer separation in the 2nd dimension. The reliability of the heartcutting process is shown by the retention time and peak area reproducibility of the low level isomeric impurity in the presence of main compound. A linear calibration curve (R2>0.995) of cis-isomer impurity was also established in the 2nd dimension.

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