科研之友
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摘要
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 F-254 TLC plates. The R-F 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 mu g band(1) for FOF (r = 0.9999) and 7-140 mu g 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 mu g band(-1), while the limit of quantification was 0.16 and 0.53 mu g band(-1) of FOF and BUD, respectively. Other aspects of the analytical validation such as accuracy, precision, specificity, and robustness were also evaluated. The proposed method was successfully applied to the analysis of the two drugs in combination in pressurized metered-dose inhaler. Therefore, the proposed method is suitable for the routine quality control of FOF and BUD in drug substance and drug product.
- 出版日期2017-2
