A Reversed Phase–High Performance Liquid Chromatographic (RP-HPLC) method has been developed for simultaneous estimation of Fluocinolone acetonide and Miconazole nitrate in bulk drug and in pharmaceutical formulation using methanol as a solvent. The compounds were well separated on a Thermo Scientific C 18 Column (150 mm*4.6 mm, 5 µm) using mobile phase consisting of Methanol: Water (65:35 v/v) at a flow rate of 1.0 mL min-1 with detection wavelength at 232 nm. The linearity ranges were 0.5-4.5 µg/mL for Fluocinolone acetonide and 200-900 µg/mL for Miconazole nitrate. The recovery amount was more than 99 %. The high recovery and low relative standard deviation confirms the suitability of the method for determination of Fluocinolone acetonide and Miconazole nitrate in ointment dosage form. The results of analysis of all methods have been validated statistically. The developed method is simple, rapid, precise and accurate, hence can be used for routine estimation of these drugs in formulations. The results were found to be within acceptance criteria according to ICH Q2 R1 guideline.
Loading....