Validated Reversed Phase High Performance Liquid Chromatographic Method for Determination of Three Novel Steroids in Bulk and Pressurized Metered - Dose Commercial Preparations Using a Common Mobile Phase

A simple and sensitive reversed phase high performance liquid chromatography (RP HPLC) method has been proposed for determination of three widely used novel steroids in bulk as well as in their pressurized metered dose commercial preparations. The steroids are Budesonide, Fluticasone propionate and Ciclesonide. These steroids are widely used in treatment of different types of respiratory disorders mainly in the form of pressurized metered dose commercial formulations. The steroids were chromatographed using methanol: acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1.0 ml/min. The retention time (RT) of Budesonide, Fluticasone propionate and Ciclesonide was found to be 3.4161 ± 0.1305 min., 3.0512 ± 0.3694 min. and 4.841 ± 0.2421 min., respectively. The linearity of Budesonide, Fluticasone propionate and Ciclesonide were in the range of 1 10 μg/ml, 1 18 μg/ml and 2 20 μg/ml, respectively. The method was validated as per ICH guidelines and successfully applied for quantification of Budesonide, Fluticasone propionate and Ciclesonide in their pure and metered dose commercial formulations, contributing to improve the quality control and to assure the therapeutic efficacy.