Unique Research for Developing a Full Factorial Design Evaluated Liquid Chromatography Technique for Estimating Budesonide and Formoterol Fumarate Dihydrate in the Presence of Specified and Degradation Impurities in Dry Powder Inhalation

Abstract

A simple LC method has been developed and validated for estimating budesonide (epimer B + A) and formoterol fumarate dihydrate in dry powder inhalation. The development results of this study make it very significant. The degradation and process impurities in EP and ChP were identified in addition to budesonide and formoterol fumarate. As of yet, no one has reported all impurities using a single method. It is a unique research because it analyzes APSD (Aerodynamic Particle Size Distribution), DDU (Delivered Dose Uniformity), BU (Blend Uniformity), Assay, and cleaning test samples. It enhances the quality of medicine and separates all organic impurities and isomers through a suitable stationary phase (YMC-Pack Pro C18, 150 × 4.6 mm × 3 μm). We optimized the chromatographic conditions: Injection volume was 20 μL, and flow rate was 1.0 mL/min. The wavelength was optimized at 220 nm. After experimental and validation results. An example is A, which contains sodium dihydrogen orthophosphate monohydrate, sodium 1-decane sulfonate, adjusted pH 3.0, and acetonitrile at a ratio of 80:20 (v/v), and B, which contains pH 3.0 buffer and acetonitrile at a ratio of 20:80 (v/v) respectively. In addition to being optimized, the test method was validated according to ICH Q2(R2).