LAUSR

Docetaxel is an anticancer that belongs to the family of taxanes and acts in the inhibition of cell proliferation through the polymerization of microtubules. The aim of this study was the development and validation a fast method by reversed-phase high-performance liquid chromatography (RP-HPLC) for quantitative analysis of docetaxel encapsulated in pegylated liposomes. The analytical method was validated for the following recognized specifications: system suitability, precision (repeatability and intermediate precision), linearity, accuracy, selectivity, detection and quantification limits and robustness. The RP-HPLC analyses were performed at a temperature of 45°C (isocratic mode). The mobile phase was composed of acetonitrile and water (65:35, v/v) and the flow rate fixed at 0.8 mL/min. The running time and wavelength were 8 min and 230 nm, respectively. The method was found to be linear, precise, selective, precise, robust, accurate, in the range of 1 -75 μg/mL (R2 = 0.9999) and the values of detection and quantification limits were 2.35 and 7.84 μg/mL, respectively. The release rates of docetaxel in pegylated liposomes were lower compared to docetaxel in solution. The RP-HPLC method developed proved to be adequate and can be effectively used to determine the in vitro release profile of docetaxel transported by pegylated liposomes. This article is protected by copyright. All rights reserved.