Determination of ethynylestradiol and norethindrone in synthetic intestinal fluid and in timed-release oral formulations.

Abstract

This study was performed to develop analytical procedures for the rapid and precise quantitation of ethinylestradiol (EE) and norethindrone (NET) in microsphere form and in synthetic intestinal fluid. High-performance liquid chromatographic procedures were used. The synthetic intestinal fluid study resulted in the development of a method capable of quantitating hormone release rate in vitro. It is described, along with the method of chromatography which enables reading of sustained-release oral contraceptive formulations.