Development and Validation of a Reversed-Phase HPLC Method for the Analysis of Budesonide in Pharmaceutical Dosage Forms

Abstract

A rapid and sensitive high-performance liquid chromatographic method
was developed for the estimation of budesonide in pharmaceutical dosage
forms. Budesonide was chromatographed on a reverse phase C-18 column
using nimesulide as internal standard in a mobile phase consisting of
methanol and water in the ratio of 80: 20 v/v. The mobile phase was
pumped at a flow rate of 0.8 mL/min, and the eluents were monitored at
241 nm. The calibration curve was linear in the range of 0.1 to 40 g/mL.
The intra- and inter-day variation was found to be less than 1% showing
high precision of the assay method. The mean recovery of the drug from
the solutions containing 5, 10 or 20  μg/mL was 98.47 ± 0.37% indicating
high accuracy of the proposed HPLC method. Due to its simplicity, rapidness,
high precision and accuracy, the proposed HPLC method may be
used for determining budesonide in bulk drug samples or in capsules.