Evaluation of the use of LC-MS in supporting stability studies for preclinical study formulations

Assessing the short-term stability of drug development candidates in one or more formulations to be used during their preclinical evaluation is a routine, but important, task. Typically, this is based on data generated by HPLC with ultraviolet detection of the species of interest and using methodology specifically developed and validated for the purpose. This work describes a feasibility study conducted into the use of HPLC with mass spectroscopic detection for work of this type. Experimental details and the results of trials with three different drugs, each in a different vehicle, are given. It was concluded that, by using mass spectroscopic detection, a well-defined strategy could be used to generate stability data, which offered advantages in terms of specificity, speed and sensitivity over that typically used.