Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam-530045, India
Budesonide is a glucocorticoid used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD). Also used to prevent difficulty breathing, chest tightness, wheezing and coughing caused by asthma. A new stability indicating RP-UFLC method has been developed and validated for the determination of Budesonide in pure and pharmaceutical dosage forms. Shimadzu Model CBM-20A/20 Alite UFLC system (Shimadzu Co., Kyoto, Japan) equipped with SPD M20A prominence photodiode array detector on Agilent C18 column was used with a mobile phase consisting of formic acid and ACN (25: 75, v/v) and flow rate 1.2 ml/min (UV detection at 247 nm). Budesonide obeys Beer-Lambert's law over a concentration range of 10–100 μg/ml. The linear regression equation was found to be y = 35317x + 3515.8 (r2 = 0.9999). The LOD and LOQ was found to be and 2.913 and 8.7643 μg/ml. Budesonide was subjected to forced degradation and the method was validated as per ICH guidelines.