Abstract

In this work are presented two methods for the simultaneous determination of 17 alpha-ethinylestradiol (EEL) and chlormadinone acetate (CMA) by second order derivative spectrophotometry. The first analytical method proposed is based in the dissolution and extraction of both drugs in acetonitrile. The solution was directly evaluated by second order derivative spectrophotometry with a smoothing factor of 8,000 and a scale factor of 10,000. The determination of EEL and CMA was carried out to 296,6 and 291.8 nm, respectively. The detection limits (3.3 sigma criterion) for EEL and CMA were 6.9 x 10(-7) and 9.8 x 10(-8) mol/L, respectively. Furthermore, a study of the effect of the excipients containing in the pharmaceutical formulation was included. Polyvidone presents greater tendency to produce interference, but its spectral bands are located between 215 and 240 nm, so these bands do not interferes spectrally in the simultaneous determination of EEL and CMA. Both drugs were extracted from the pharmaceutical formulation with acetonitrile, obtaining a good recovery relative to the nominal content. The second method is a screening method and was applied in fortified drinking water. In this method, drugs were extracted in chloroform, which was then removed with N-2 and the residue was redissolved in acetonitrile. Due to the difference in the procedure in relation to the pharmaceutical formulation a new analytical parameters were obtained. For EEL this parameters were very similar to those obtained directly in solution, however these were higher for CMA, which could be attributed to that under these conditions was found a higher standard deviation of the blank. Recoveries of fortified samples were 81.8 +/- 1.5% and 101.1 +/- 0.73% for EEL and CMA, respectively.