Development and validation of a reverse-phase high-performance liquid chromatography method for indacaterol and budesonide analysis
DOI:
https://doi.org/10.26452/fjphs.v5i2.725Keywords:
Stability, Indacaterol, Budesonide, Stress conditions, Analytical methodAbstract
An efficient, precise, and accurate technique for the concurrent estimation of compounds Indacaterol and Budesonide in pharmaceutical preparations were developed. The analysis utilized an Xterra C18 (4.6 × 150 mm, 5.0 µm) chromatographic column used in combination with a mobile phase ratio of buffer (0.1% orthophosphoric acid): acetonitrile (40:60% v/v) and a flow rate is 1 mL/min. The detection was performed at a wavelength of 220 nm. The recorded retention times for Indacaterol and Budesonide were 3.124 minutes and 4.270 minutes, respectively. Respectively. The percentage recovery was 100.01% for Indacaterol and 100.34% for Budesonide. The method demonstrated limits of detection (LOD) of 0.3 µg/mL and 0.6 µg/mL and limits of quantification (LOQ) of 1.0 µg/mL and 1.9 µg/mL for Indacaterol and Budesonide. Regression equations confirmed linearity within the established range. Stress degradation studies (acid, base, peroxide, thermal, and photostability conditions) indicated that the percentage degradation of Indacaterol and Budesonide remained within acceptable limits, ensuring method robustness.
