Abstract
As an alterative to photodiode array or mass spectral analysis, a heart-cutting two-dimensional liquid chromatography technique (2D-LC) can be utilized to assess peak purity. In this work, the strengths of the heart-cutting 2D-LC technique are presented by highlighting a case study where a co-eluting impurity present at 0.8 % was non-detectable using traditional methods. However, when fractions taken across the main peak were re-assayed using an orthogonal method, this peak was readily observed. With modern switching valves and up-to-date chromatography software, implementing this technique into a validation protocol for assessing peak purity is simple and can be accomplished through only minor modifications to existing HPLC equipment.
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Acknowledgments
We would like to thank our colleagues at Merck and Company for their valuable comments and support, most notably Peter Sajonz for his thoughtful discussions.
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R. Helmy and F. Bernardoni are primary authors.
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Lee, C., Zang, J., Cuff, J. et al. Application of Heart-Cutting 2D-LC for the Determination of Peak Purity for a Chiral Pharmaceutical Compound by HPLC. Chromatographia 76, 5–11 (2013). https://doi.org/10.1007/s10337-012-2367-5
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DOI: https://doi.org/10.1007/s10337-012-2367-5