Abstract：
:A field-amplified sample stacking (FASS) and capillary zone electrophoresis (CZE) method is described for the quantification of ambroxol hydrochloride in human plasma, following liquid-liquid extraction in the 96-well format. The separation was carried out at 25 °C in a 31.2 cm × 75 μm fused-silica capillary with an applied voltage of 15 kV. The background electrolyte (BGE) was composed of 6.25 mM borate-25 mM phosphate (pH 3.0) and 1mM β-cyclodextrin. The detection wavelength was 210 nm. Clean-up and preconcentration of plasma biosamples were developed by 96-well format liquid-liquid extraction (LLE). In this study, FASS in combination with β-cyclodextrin enhanced the sensitivity about 60-70 fold in total. The method was suitably validated with respect to stability, specificity, linearity, lower limit of quantitation, accuracy, precision, extraction recovery and robustness. The calibration graph was linear for ambroxol hydrochloride from 2 to 500 ng/ml. The lower limit of quantification was 2 ng/ml. The intra- and inter-day precisions of lowest limit of quantification (LLOQ) were 9.61 and 11.80%, respectively. The method developed was successfully applied to the evaluation of clinical pharmacokinetic study of ambroxol hydrochloride tablet after oral administration to 12 healthy volunteers.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Li J,Bi Y,Wang L,Sun F,Chen Z,Xu G,Fan Gdoi
10.1016/j.jpba.2012.02.026subject
Has Abstractpub_date
2012-07-01 00:00:00pages
218-24eissn
0731-7085issn
1873-264Xpii
S0731-7085(12)00120-3journal_volume
66pub_type
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