Pharmacokinetic Study of Ambroxol Hydrochloride Solution for Inhalation in Lung Tissue of Rats
Objective To investigate the pharmacokinetic characteristics of Ambroxol Hydrochloride Solution for Inhalation in the lung tissue of rats.Methods Ultra-high-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method was used to determine the content of ambroxol hydrochloride in the lung tissue of SD rats.The chromatographic column was the Waters Acquity UPLC BEH C18 column(100 mm×2.1 mm,1.7 µm),the mobile phase was 0.1% formic acid aqueous solution-acetonitrile(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 35℃,and the injection volume was 5 µL.The electron spray ionization was adopted with the positive-ion multiple reaction monitoring mode.The lung tissues of rats were collected before giving Ambroxol Hydrochloride Solution for Inhalation and after 0.083,0.25,0.5,1,2,4,6,8,12,24 h of giving this drug(equivalent to 22.5 mg ambroxol hydrochloride),and pharmacokinetic parameters were calculated by the DAS 3.0 software.Results The linear range of ambroxol hydrochloride in lung tissue of rats was 10-1 000 ng/mL(r=0.998 6,n=7).The results of precision,stability,recovery tests and matrix effect all met the methodological requirements.The half-life(t1/2)was 4.33 h,the peak concentration(Cmax)was 3 997.40 ng/g,the area under the plasma concentration-time curve(AUC0-t)was 4 311.88(ng·h)/g,the mean residence time(MRT0-t)was 2.74 h,and the clearance rate was 5.05(L·h)/kg.Conclusion This method is easy,accurate and reliable,which can be used for the pharmacokinetic study of Ambroxol Hydrochloride Solution for Inhalation in lung tissue of rats.
Ambroxol Hydrochloride Solution for Inhalationratlung tissuepharmacokineticsUPLC-MS/MScontent determination
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