HPLC/UV or bioassay: Two valid methods for posaconazole quantification in human serum samples

Abstract

In this paper we report on the development and validation of two different methods for posaconazole quantification from serum samples, HPLC/UV and bioassay. Both methods have been validated according to international guidelines and were also applied to the analysis of 61 trough serum samples from treated patients. A good correlation between both methods was observed. The HPLC method, more laborious and expensive, was demonstrated to be more accurate, precise and faster (analytical range 0.125-16μg/mL, accuracy between -2.48 and 3.70% and precision between 2.77 and 5.93%, with an analytical run time of 11min), making it a valuable tool for reference laboratories that centralize high numbers of samples. The microbiological method, however, is simple and offers sufficient precision and accuracy (analytical range 0.125-16μg/mL, accuracy between -8.10 and 3.77% and a precision between 4.52 and 10.07%), to be used to monitor posaconazole. It may be a valid alternative to chromatographic methods in clinical laboratories without specialized facilities. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.