The Pharmaceutical industry is highly regulated to insure products are safe and effective. Over the counter cough/cold product contain 1-4 actives some of which are highly polar. Along with potential degradation products, preservatives, dyes and flavor compounds, separations can be extremely challenging especially in a surveillance setting given the vast number of products. In addition, some of these compounds are chiral. The separation of many complex polar mixtures is accomplished using ion pair reagents or phosphate buffer. These reagents unfortunately reduce the efficiency of ionization need to identify mixture components and impurities by LCMS. These materials are produced around the world. In some cases, it is necessary for regulatory groups to check samples for contamination degradation or adulteration. Methods In this work an existing compendial methods is utilized to separate components of a cold medicine using a C18 column (InfinityLab Poroshell 120 SB-C18 using a reversed phase ion pair based mobile phase. Studies were performed utilizing a 2D-LC system (Agilent 1290 Infinity II) hyphenated to a quadrupole mass spectrometer (G6150). The chromatographic system includes an achiral column (InfinityLab Poroshell 120 SB-C18) in first dimension and a chiral column (InfinityLab Poroshell 120 Chiral-T, or InfinityLab Poroshell 120 Chiral-V) in second dimension. When no chiral separation of the components is desired, a second reversed phase or HILIC column is utilized with a formic acid/formate mobile phase.

2D HPLC coupled with MS to examine cold medicines using compendial methods as the first dimension

2019 Fall National Meeting

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