AERODYNAMIC CHARACTERIZATION OF BECLOMETHASONE DIPROPIONATE FROM BECLATE-50 INHALER® BY HPLC-UV

Author： Sahib Mohanad Naji Darwis Yusrida Khiang Peh Kok Fung Tan Yvonne

ISSN： 1082-6076

Source： Journal of Liquid Chromatography & Related Technologies, Vol.34, Iss.8, 2011-01, pp. : 613-621

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Abstract

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®. The mobile phase consisted of a mixture of acetonitrile and 10 mM ammonium acetate (70:30% v/v) adjusted to pH 5 with orthophosphoric acid. The HPLC analysis was run at a flow rate of 1 mL/min using a C18 column at a UV detection wavelength of 254 nm. 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 µg/mL (r2 = 0.9999) with limit of detection and limit of quantification of 0.01 and 0.03 µg/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®.