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Assay Method Development and Validation for Simultaneous Estimation of Mometasone Furoate and Azelastine HCL for Nasal Spray by RP-HPLC

Poonam D. Dighe, Vijay S. Wakale, Dama G.Y., Shridhar S. Shejwal, Kiran K. Shinde, Arshu P. Patel, Soniya S. Satpute

Abstract


A simple, precise, accurate, method was developed and validated for analysis of Mometasone Furoate and Azelastine Hydrochloride 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 potassium dihydrogen, phosphate buffer and acetonitrile. Other HPLC parameters were flow rare 1 ml/min, detection wavelength 239 nm, injection volume 20 µl and column temperature 30°C. The developed method was further validated with respect to linearity, precision, accuracy, specificity and robustness. The results obtained were within the acceptance criteria as per ICH guidelines.


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