Assay Method Development and Validation for S...

Assay Method Development and Validation for Simultaneous Estimation of AzelastineHCl and Fluticasone Propionate Nasal Spray by RP-HPLC

Author Name : Kiran K. Shinde, Sumit R. Deore, Nachiket S. Dighe

ABSTRACT A simple, precise, accurate, method was developed and validated for analysis of Azelastine Hydrochloride and Fluticasone Propionate in nasal spray formulations. For development different chromatographic condition and stress conditions like acid, base, peroxide, thermal and humidity as per ICH guidelines were used. Method was developed on reversed-phase C18 column using a mobile phase consisting of Ammonium Dihydrogen Phosphate Buffer: Acetonitrile. Other HPLC parameters were: flow rare 1.2 ml/min; detection wavelength 239 nm; injection volume 20 μl and column temperature 300 C. The developed method was further validated with respect to linearity, precision, accuracy, and robustness. The results obtained were within the acceptance criteria as per ICH guidelines.