Validation of Novel Analytical RP-HPLC Method for determination of Formoterol Fumarate and Budesonide in Inhalation Suspension Pharmaceutical Dosage Form

Abstract

Formoterol Fumarate and Budesonide inhalation suspension is prescribed for treatment of Asthmatic patient. Formoterol Fumarate is anti-asthmatic drug (Bronchodilator) and Budesonide is Anti Inflammatory Drug (Glucocortico steroid) drug. A bronchodilator is a substance that dilates the bronchi and bronchioles, decreasing resistance in the respiratory airway and increasing airflow to the lungs while Anti Inflammatory drug is used for the treatment of inflammation occurred on respiratory tract. The present study aimed to Validate HPLC method for combined determination of Assay of Formoterol Fumarate and Budesonide Analytes. This study covers Precision, Limit of Detection, Limit of Quantification, Linearity, Accuracy, Robustness, Ruggedness, Solution stability and Specificity. The chromatographic method uses a reversed phase column Hypersil ODS 125mm ×4.0mm x 5μm). The mobile phase was prepared by mixing Acetonitrile: Phosphate buffer (35:65, %v/v) at flow rate 1.0ml/min with Ultraviolet and Diode array detector at wavelength 215nm, column oven adjusted to 40°C and with injection volume 50μL. The method Found Precise, Accurate, Linear, Rugged, Robust and Sensitive. The method showed a successful application for determination of Formoterol Fumarate and Budesonide in Inhalation suspension pharmaceutical formulation.