Development and Validation of Novel HPLC and Extraction Method for Determination of UC 781 in Vaginal Tissue

The nonnucleoside reverse transcriptase UC781 is an effective agent to inhibit direct infection of mucosal tissue to prevent dissemination of virus by migratory cells. It is important to develop bioanalytical method to quantitate the drug level in vaginal tissue.This article reports a novel HPLC analytical method for analyzing UC781 in the New Zealand white rabbit’s vaginal tissue. The method developed is described and validated. The tissue prepared by optimized “Bead Beating” technique using Precellys 24, followed by liquid-liquid extraction. The extraction procedure proved to be efficient with a high extraction percentage and prevents analyte degradation. The method was validated over the range of (50-20000 ngmL 1).Thevalidation statistics indicated that the method is accurate over three QC (n=26) concentrations from 101 % to 110 %, and precise (intraday, n=5) and (interday, n=26) ranged from 4.7 % to 8.8 % and 8.0 to 12.0 %, respectively. All results which were obtained from three different lots of tissue indicating the absence of matrix effects on the final data. This method could be readily used for investigational or clinical monitoring of other organ tissue drug concentrations with minimal further optimization.