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

摘要

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.