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KMID : 0369820110410050309
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Jorunal of Korean Pharmaceutical Sciences
2011 Volume.41 No. 5 p.309 ~ p.315
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Bioequivalence Assessment of Acephyll® Capsule to Surfolase® Capsule (Acebrophylline HCl 100 mg) by Liquid Chromatography Tandem Mass Spectrometry
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Nam Kyung-Don
Seo Ji-Hyung
Yim Sung-Vin
Lee Kyung-Tae
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Abstract
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A sensitive and specific liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the analysis of ambroxol (active moiety of acebrophylline). After acetonitrile precipitation of proteins
from plasma samples, ambroxol and the domperidone (internal standard, IS) were eluted on a C18 column. The isocratic
mobile phase was consisted of 10 mM ammonium acetate and methanol (10 : 90, v/v), with flow rate at 0.2 mL/min. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z 379.2→264.0 and the m/z 426.2→175.1 transitions for ambroxol and the IS, espectively. Twenty four healthy Korean male subjects received two capsules (100 mg × 2) of either the test or the reference ormulation of acebrophylline HCl in a 2 × 2 crossover study, this was followed by a 1week washout period between either formulation AUC0-t (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 (e.g., log 0.8964 - log 0.9910 for AUC0-t log 0.8690 - log 1.0750 for Cmax). The major parameters, AUC0-t and Cmax met the criteria of Korea Food and Drug Administration for bioequivalence indicating that Acephyll® capsule (test) is bioequivalent to Surfolase® capsule (reference).
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KEYWORD
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Liquid chromatography/tandem mass spectrometry, Ambroxol, Bioequivalence, Acephyll(R) capsule, Surfolase(R) capsule
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