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Chromatographia

, Volume 76, Issue 1–2, pp 5–11 | Cite as

Application of Heart-Cutting 2D-LC for the Determination of Peak Purity for a Chiral Pharmaceutical Compound by HPLC

  • Claire Lee
  • Jia Zang
  • James Cuff
  • Neil McGachy
  • Theresa K. Natishan
  • Christopher J. Welch
  • Roy Helmy
  • Frank BernardoniEmail author
Original

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.

Keywords

Heart-cutting HPLC Two-dimensional HPLC 2D-LC Peak purity assessment Pharmaceutical analysis Method validation 

Notes

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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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Claire Lee
    • 1
  • Jia Zang
    • 1
  • James Cuff
    • 1
  • Neil McGachy
    • 1
  • Theresa K. Natishan
    • 1
  • Christopher J. Welch
    • 1
  • Roy Helmy
    • 1
  • Frank Bernardoni
    • 1
    Email author
  1. 1.Merck Research LaboratoriesRahwayUSA

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