Eric S. Grumbach, Diane M. Diehl and Jeffrey R. Mazzeo, Waters Corporation
Pharmaceutical formulations used to treat the common cold often contain multiple active ingredients to treat different symptoms. These actives can include combinations of decongestants, antihistamines, pain relievers, cough suppressants and expectorants in addition to numerous excipients, all of which exhibit different chemical properties, including polarity. It is this wide range of analyte polarities that often makes chromatographic methods development difficult.
UPLC technology was used to develop a single chromatographic method for the analysis of 20 of the most common pharmaceutical formulations targeted to relieve symptoms associated with the common cold. A new high strength silica (HSS) UPLC stationary phase was used to develop a single chromatographic method for the analysis of a number of possible formulation compositions. This stationary phase was selected because of its ability to enhance the retention of polar analytes while also having good chromatographic selectivity of hydrophobic species.
Reference standards were prepared in a solution of 75:25 (v/v) water:methanol containing 0.2% formic acid at a concentration of 25 μg/mL for each component, except acetaminophen, which was 12.5 μg/mL and its respective impurities, 4-aminophenol, 4-nitrophenol and 4-chloroacetanilide, were prepared at a concentration of 2.5 μg/mL
A mixture of standards of 20 common components of cold medicine formulations including active ingredients, impurities and counter ions, was separated on a 2.1 × 100 mm, ACQUITY UPLC HSS T3, 1.8 μm column, as depicted in Figure 1. A listing of elution order, relative retention, and USP resolution of all components is listed in Table 1. Retention factors range from 0.52 to 10.47. All components were baseline separated in less than 7 minutes and had resolution factors of 1.65 or greater.
A fast, high resolution chromatographic method was developed for pharmaceutical formulations targeted to relieve symptoms of the common cold by utilizing a new high strength silica (HSS) UPLC stationary phase. This single chromatographic method can be used to rapidly analyse a number of possible formulation compositions containing different active ingredients.
© 2007 Waters Corporation. Waters, UPLC, ACQUITY UPLC, Empower, and The Science of What's Possible are trademarks of Waters Corporation.
Eric S. Grumbach, Diane M. Diehl and Jeffrey R. Mazzeo, Waters Corporation, Milford, Massachusetts, USA.
34 Maple Street, Milford, Massachusetts 01757, USA
tel. +1 508 478 2000 fax +1 508 478 1990