Abstract
A simple and robust thin-layer chromatography (TLC) method has been developed and validated for the simultaneous quantitative analysis of formoterol fumarate (FOF) and budesonide (BUD) in pressurized metered-dose inhaler (pMDI). Separation was carried out by using silica gel 60 F254 TLC plates. The Rf values were 0.50 ± 0.01 for FOF and 0.74 ± 0.01 for BUD when isopropanol—ammonia (8:2, v/v) was used as the mobile phase. The plates were scanned using a CAMAG spectrodensitometer at 214 nm. The regression plots revealed good linear relationships of concentration ranges 0.2–4 μg band−1 for FOF (r = 0.9999) and 7–140 μg band−1 for BUD (r = 0.9998). Method validation was performed in accordance with the International Conference on Harmonization (ICH) guidelines. Accuracy was checked by conductive recovery studies; mean percentage recovery was 99.69% ± 0.97 for FOF and 100.03% ± 1.41 for BUD. The limit of detection was 0.05 and 0.17 μg band−1, while the limit of quantification was 0.16 and 0.53 μg band−1 of FOF...
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