DETERMINATION OF SELENIUM IN SOFT GELATIN CAPSULES BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHODOLOGY

Abstract

Selenium is an essential trace element for human health and deficiency of this nutrient frequently causes disorders such as diabetes, Keshan disease, thyroid dysfunction and cognitive limitation. Organic and ionic selenium are highly bioavailable, but elemental selenium is hardly available. In the development of a pharmaceutical product, it is necessary to use a specific analytical method to quantify the active ingredient in a formulation. High performance liquid chromatography has several applications and, being automated, it allows to perform analyses quickly and efficiently and to be applied in routine use in the analysis of quality control and stability of the drug. The chromatographic conditions used are L1 Octadecyl silane column 300 mm x 3.9 mm x 10 µm, oven temperature at 30 ºC, wavelength at 330 nm, mobile phase composed of Acetonitrile and water in 86:14 ratio, injection volume 100 µL. The evaluated validation parameters confirmed specificity, precision with coefficient of variation less than 2 %, accuracy of 100.64 % and robustness after 24 hours with C.V. (%) ≤ 2 %. Concluding that the proposed method is suitable for the quantification of selenium in gelatin capsules.