Rapid Spectrophotometric methods for the determination of two novel steroids in bulk and pressurised metered - dose preparations

Two simple, rapid, accurate, precise, reliable and economical spectrophotometric methods have been proposed for determination of two widely used new steroids in bulk as well as in pressurised metered dose preparations. The steroids are Ciclesonide and Fluticasone propionate. Both steroids are widely used in the treatment of various types of respiratory disorders. The developed methods for determination of both the steroids are direct spectrophotometric method and first derivative spectrophotometric method. The developed methods show best results in terms of linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) for determination of pure drugs and pressurised metered dose preparations. The range value for Ciclesonide and Fluticasone propionate were found to be 5-35 μg/ml and 3-27 μg/ml respectively. For Ciclesonide, the values of LOD and LOQ were 0.1113 μg/ml and 0.3372 μg/ml respectively and for Fluticasone propionate, the values of LOD and LOQ were found to be 0.4074 μg/ml and 1.234 μg/ml respectively using direct spectrophotometric determination. With first derivative spectrophotometry, the value of LOD and LOQ for Ciclesonide were found to be 0.5171 μg/ml and 1.567 μg/ml respectively and for Fluticasone propionate, the values of LOD and LOQ were found to be 0.6507 μg/ml and 1.972 μg/ml respectively. The precision values were less then 2 % in terms of % R.S.D. for both drugs in both the methods. The common excipients and additives did not interfere in their determinations. The results obtained by the proposed methods have been statistically compared by means of Student t-test and by the variance ratio F-test.