DEVELOPMENT AND VALIDATION OF A BIOANALYTICAL METHOD FOR OCCIDIOFUNGIN

Abstract

Fungal infections caused by opportunistic pathogens can be severe and have been growing in prevalence. Many clinically relevant pathogens have resistance to or are developing a resistance to the commonly used treatments. Occidiofungin is a novel cyclic peptide that is active against a wide range of fungi and has a novel mechanism of action. As such, occidiofungin is being developed for use in treating vulvovaginal candidiasis and its recurrent form. This study describes development and validation of bioanalytical methods for the quantification of occidiofungin in rat and rabbit plasma. These methods are used to accurately and precisely quantify small amounts of occidiofungin in rat and rabbit plasma. Validation of this method was performed within the linear range of 150 to 15000 ng/mL for accuracy and precision in rat and rabbit plasma. Calibration curve linearity, stability of drug in plasma was established in quality controls. Extract stability, matrix effects and recovery of drug in the extract was also determined. This validated method allows for further studies into the absorption, distribution, metabolism, and excretion in addition to other pharmacokinetic studies.