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Development and validation of a reverse - phase high - performance liquid chromatography method for indacaterol and budesonide analysis

Year: 2025
Type: article
Abstract: 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 perfo rmed 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 demonst rated 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 .
Language: English
Field: Chemistry
Open Access status: diamond
OpenAlex ID: W4409235058
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