| A simple, reproducible RP-HPLC method was developed for the determination of the ambroxol hydrochloride in human plasma and the chromatographic conditions were optimized:Lidocaine was taked as the internal standard, the plasma sample extracted with aether, chromatographic column was Scienhome C18 (200 mm×4.6 mm, 5 mm) and the mobile phase was composed of acetonitrile:methylalcohol:0.01mol /L phosphatic buffer(pH 7.0):tetrahydrofuran(35:35:27.5:2.5, v/v/v/v), the flow rate was 1.0 mL/min, the injection quantity was 50μL, the column temperature was the room temperature, Detection wavelength was 245nm. The retention time of ambroxol hydrochloride and lidocaine were about 6.8min and 7.8min, respectively.The resolution was over than 1.5. The tailing factor was smaller than 1.2. The typical standard curve was y=0.008x+0.091 r=0.9994. The linear scope of ambroxol hydrochloride's concentration was 20.0～320 ng/mL. The lower limit of quantitation was 20.0 ng/mL. The RSD of within-day and day to day precision were 3.8～10.0% and 4.5～8.4%, respectively.The method can be used for the dynamics research of the medicine metabolism of ambroxol hydrochloride in human plasma ang the drug's quality control.The HPLC method was used to the test formulationa and the reference formulation to research the human bioavailability. A double period and two preparations crossing design was adoped to the experiment. The medicine was solely gived to 22 healthy male volunteers, respectively.Then we measured ambroxol hydrochloride's concentration in humen's plasma. The test result showed:the test formulationa:Tmax=2.00±0.15, Cmax=159.6±38.80 ng/ml, AUC0-t=1145.9±281.8 ng·h/ml, AUC0-8=1370.9±329.3 ng·h/ml; the reference formulation: Tmax=2.02±0.11h, Cmax=159.3±45.90 ng/ml, AUC0-t= 1095.5±296.7 ng h/ml, AUC0-8=1322.9±360.3 ng h/ml. The relative bioavailability of the test formulation was105.7±10.14% and two formulations were bioequivalent according to the results of ststistical analysis. |
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