“Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation”

Abstract

An analytical method for formoterol fumarate and fluticasone propionate in dry powder inhaler formulations was further developed and validated. Separation was performed on a HiQ Sil C18HS, 2504.6 mm, and 5 µm column using cell segments in acetonitrile:

in 0.01 M ammonium dihydrogen phosphate (80:20% v/v) at a slide speed of 1 mL/min. I did. Detected at 215.0 nm. The technique has been proven in relation to his ICH requirements for linearity, accuracy, precision, specificity, and robustness. The results obtained meet the popularity requirements of the ICH guidelines.