科研之友
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摘要
A simple yet sensitive high performance liquid chromatography (HPLC) method was developed and validated for the determination of aerodynamic characteristics of the emitted dose of beclomethasone dipropionate from Beclate-50 Inhaler (R). The mobile phase consisted of a mixture of acetonitrile and 10mM ammonium acetate (70:30% v/v) adjusted to pH 5 with orthophosphoric acid. The HPLC analysis was run at a flow rate of 1mL/min using a C18 column at a UV detection wavelength of 254nm. The method was validated for specificity, linearity, precision, accuracy, limit of quantification, limit of detection, robustness, and solution stability. The calibration curve was linear over a concentration range of 0.03-62.50 mu g/mL (r2=0.9999) with limit of detection and limit of quantification of 0.01 and 0.03 mu g/mL, respectively. The intra-day and inter-day precision and accuracy were between 0.02 and 1.89% and -1.08 and 2.62%, respectively. The method was successfully applied to the aerodynamic characterization of both the fine particle and the emitted doses of beclomethasone dipropionate from Beclate-50 Inhaler (R).
- 出版日期2011
