SIMULTANEOUS REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) ESTIMATION OF AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE, AND PHENYL ETHYL ALCOHOL IN DYMISTA (MEDA) NASAL SPRAY

Abstract

This work reported a reverse phase-high performance liquid chromatography method for quantitative estimation of Azelastine Hydrochloride, Fluticasone Propionate, and Phenylethyl Alcohol in Nasal Spray formulation. The assay involved an isocratic elution of these components by using Intersil Octadecylsilane (C18) column (25 cm x 4.6 mm x 5 μm) using mobile phase composition of Buffer: Solvent Mixture (40:60 %v/v) and pH adjusted to 6.5 with dilute orthophosphoric acid. The flow rate was 1.4 mLmin-1 and the analytes are monitored at 254 nm. Separation was completed within 20 minutes. Calibration curves were linear with correlation coefficient more than 0.99 over a concentration range of 50%, 75%, 100%, 125%, and 150% for Azelastine Hydrochloride, Fluticasone Propionate and Phenylethyl Alcohol. The method was proven to be accurate between 50 to 150% with 98 to 102 % recovery of the actives from a spiked placebo. The method was shown to be precise yielding acceptable results for the system reproducibility and method repeatability. All the validation parameters were within the acceptance range according to International Conference on Harmonization norms. The developed method is simple and rapid which could be applied for routine estimation of the formulation.