Reverse Phase High Performance Liquid Chromatography Method for Simultaneous Estimation of Budesonide and Formoterol in Pure and Tablet

A simple, rapid and reliable reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Budesonide and Formetrol in both pure drug substance and tablet dosage forms. Chromatographic separation was achieved using X-Bridge C18 column (4.6 × 150 mm, 5 μm) maintained at ambient temperature, with a mobile phase consisting of Methanol and Water in the ratio of 35:65 (v/v). The flow rate was set at 1.0 mL/min, and the detection was carried out using a UV detector at 235 nm. A 10 μL injection volume and a total run time of 8 minutes allowed efficient and rapid separation of both analytes. This developed method exhibited good resolution, satisfactory peak symmetry and high reproducibility. The parameters were evaluated according to ICH guidelines, the parameters such as linearity, accuracy, precision, specificity, robustness and system suitability. The validated results were found to be within acceptable limits. The validated RP-HPLC method is suitable for quality control analysis of Budesonide & Formoterol in pharmaceutical dosage forms.