Determination of Norgestimate and Ethinyl Estradiol in Tablets by High-Performance Liquid Chromatography

Abstract

A rapid, simple, stability-indicating assay procedure for norgestimate [(+)-13-ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate], a new progestational agent, and ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol) in single-and composite-tablet analyses was developed using high-performance liquid chromatography. Norgestimate and ethinyl estradiol were extracted from the tablet matrix with methanol containing an internal standard. An aliquot was chromatographed on a 5-μm, reversed-phase column using water:tetrahydrofuran:methanol solution (65:25:10 v/v/v) as the mobile phase. The selectivity of the chromatographic system for intact norgestimate and ethinyl estradiol was demonstrated by resolving both compounds from various potential degradation products of each compound. An essential property of the chromatographic system was its ability to separate norgestimate as its syn and anti isomers. The method is linear, quantitative, and reproducible.