Determination of the Concentration of Ambroxol Hydrochloride in Human Plasma with RP-HPLC
- VernacularTitle:高效液相色谱法测定人血浆中盐酸氨溴索浓度
- Author:
Shengrong GE
;
Furong AN
;
Huiming CAO
;
Jing YUAN
- Publication Type:Journal Article
- Keywords:
ambroxol hydrochloride;
pharmacokinetics;
HPLC
- From:
China Pharmacy
1991;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:A RP-HPLC method was established to determine the concentration of ambroxol hydrochloride in human plasma.METHODS:Waters HPLC instrument was used with the Hypersil BDS C 18 column(5?m,250mm?4.6mm). Ditiazem hydrochloride was chosen as the internal standard.The mobile phase was composed of acetonitrile-methyl alcohol-0.01mol/L phosphatic buffer(pH7.0)-tetrahydrofuran(35∶35∶27.5∶2.5).Flow rate was1.0ml/min.Detection wavelength was242nm.A single oral dose of90mg imported ambroxol hydrochloride tablet was given to9healthy male volunteers.Ambro xol concentration in plasma was assayed.RESULTS:The standard curve of ambroxol hydrochloride was linear in the range of10～640ng/ml.The minium detection concentration was10ng/ml.The extraction recovery was more than90%.A one-compartment open pharmacokinetic model was adopted in ambroxol plasma concentration-time data analysis.The main pharmac okinetic parameters were as follows:C max =(226.53?34.59)ng/ml,T max =(1.82?0.80)h,T 1/2ke =(6.27?0.66)h,AUC 0～24 =(2363.55?448.86)ng/(h?ml).CONCLUSION:The method is simple.The sensitivity and accuracy are high.It is applicable to study the pharmacokinetics of ambroxol hydrochloride in healthy male volunteers.
