Novel eco-friendly chromatographic determinations of hydrocortisone acetate, fusidic acid, their pharmacologically active impurities and pharmaceutical excipients: a comparative study

Abstract

The main aim of the green chemistry is to replace hazardous analytical methodologies with eco-friendly ones to decrease the use of hazardous chemicals and their effects on the environment and human health. Two novel more environmentally friendly HPTLC and HPLC–DAD chromatographic methods were developed and validated, for the first time, for quantitation of hydrocortisone acetate, hydrocortisone (hydrocortisone acetate potential impurity), fusidic acid, 3-ketofusidic acid (fusidic acid metabolite, impurity and related substance) and preservative excipients (methyl and propyl parabens) in FUSI-ZON® cream and in pure form. For the proposed HPTLC method, the green developing system composed of ethyl acetate: ethanol: acetone (8:1:1, by volume) was used, with scanning of the chromatographic bands at 230 nm. Dionex® chromatograph was used for HPLC–DAD method and the chromatographic separation was performed on an XBridge® C8 column using isocratic mode and a flow rate of 1.8 mL min−1 with a mobile phase composed of methanol: water (50:50, by volume) and detection at 230 nm. The developed methods were successfully applied for quantification of the parent drugs along with their pharmacologically active impurities and excipients in the lowest possible concentration with minimal environmental waste and short analysis time. By comparing the greenness profiles, the proposed methods have been demonstrated to be environmentally friendlier than previously reported methods.