Development and validation of a new stability indicating RP-HPLC method for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard

Abstract

Budesonide is a glucocortico steroid used for the treatment of nasal polyposis, asthma and Crohn’s disease. A stability indicating RP-HPLC method has been developed and validated for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard, Etoricoxib. Mobile phase including a mixture of formic acid: acetonitrile: methanol (25: 10: 65) was chosen for the chromatographic study with flow rate 1.0 ml/min. The PDA detection was carried at 240 nm and the elution was achieved on isocratic mode using Zorbox C18 column. Beer-Lambert’s law was obeyed over a concentration range 0.05-120 µg/ml and the linear regression equation was y = 0.0489x + 0.003 with correlation coefficient 0.9997). The LOQ and LOD was found to be and 0.0393 and 0.1192 µg/ml. Stress degradation studies such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal degradation were performed. The method was validated for the parameters linearity, precision, accuracy, robustness as per ICH guidelines and the proposed stability indicating liquid chromatographic method was found to be simple, accurate, precise and robust and can be applied for the assay Budesonide formulations.