A NovelHPLC Method for Assay of SN-38 in Nanoparticles

SN-38 is an active metabolite of rinotecan, a derivative of camptothecin that is for the treatment of recurrent, metastatic colorectal cancer (1). However, the development of this drug has been largely hindered by the poor solubility and stability of SN-38 in pharmaceutically acceptable solvents (2). A novel and well-characterized PLGA nanoparticles based formulation of SN-38 was developed that would overcome the aforementioned problems. To support ongoing formulation development, a simple and reproducible analytical method was needed. The objective of this study was to develop a simple HPLC/UV method for determination of SN-38 in PLGA nanoparticles