Improved Analytical Recovery by Taking into Account Sample Matrix and Chromatographic Instrumentation

摘要

Developing a robust analytical method for pharmaceutical products is always challenging. A lot of effort has been devoted to chromatographic separations, column selections, and quick analysis turnaround time. On the other hand, less attention has been paid to sample preparation and/or to the subtle differences in various chromatographic instrumentation. Matrix effect seems to be more of a concern in bioanalytical samples or for LC-MS studies [1]. Different from prescription medicinal products, the compositions of over-the-counter (OTC) drug products tend to be complicated due to the presence of a variety of ingredients (multiple drug substances, inert but functional excipients, flavors, dyes, etc.). Many excipients used in OTC products are intended to achieve fast onset effects, provide pleasant experiences, and improve consumer compliance. However, the added "inert" ingredients can not only sometimes cause product instability, but can also give big challenges to analytical scientists [2].