ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATIONOF BUDESONIDE AND FORMOTEROL IN BULK AND DOSAGE FORM USING RP-HPLC METHOD

The present research work related to new method development of Formoterol Fumarate and Budesonide was found satisfactory, simple, precise, accurate with good resolution, shorter retention time and among the other degradation products both Formoterol Fumarate and Budesonide were well separated with all accurate results. Low limit of quantitation and limit of detection makes this method suitable for use in quality control. The less retention time obtained for the both drugs which reduces the run time enhances the usage of this method. This is the first reported method for stability indicting simultaneous quantitative analysis of Formoterol Fumarate and Budesonide, and is a significant advance in chromatographic analysis of such pharmaceutical mixtures.. Forced degradation study results have shown good separation from degradation peaks. Hence we can clearly say that the proposed method is Economic, stable and truly novel validated method than the other reported methods.In the present developed method the acceptable validation parameters makes this method of analysis more acceptable for the routine analysis in quality control department in industries approved testing laboratories,bio-pharmaceutical and bio-equivalence studies and in clinical pharmacokinetic studies. Key Words: Formoterol Fumarate , Budesonide, RP-HPLC.