Development of a Method to Evaluate the Release Profile of Tamoxifen from Pegylated Hybrid Micelles

Abstract

Studies of in vitro release profiles are important during the development of drug delivery systems. This article describes the development and validation of a RP-HPLC method for the quantification of drug released from tamoxifen-loaded DSPE-PEG(2000)/TPGS micelles and the determination of the best dissolution medium and apparatus for this assay. The method showed specificity, linearity, precision, accuracy, and robustness for the parameters evaluated (range 0.25–20.0 µg mL⁻¹). The best dissolution medium was 1.0 mol L⁻¹ sodium salicylate, pH 7.4, and the most suitable apparatus was a PVC tube with one end covered with a dialysis membrane. This method was shown to be useful for tamoxifen quantification in in vitro release studies.

Keywords:

• analytical development and validation
• drug delivery systems
• in vitro release profile
• hybrid pegylated micelles
• RP-HPLC quantification
• tamoxifen

Acknowledgments

The authors thank to Dr. Marcelo Claro de Souza for the statistical analysis and FCFRP-USP.