Simultaneous determination of amlodipine,valsartan and hydrochlorothiazide by LC-ESIMS/MS and its application to pharmacokinetics in rats  

作　　者：Shankar Ganesh Gadepalli Pragney Deme Madhusudana Kuncha Ramakrishna Sistla 

机构地区：[1]Pharmacology Division, Indian Institute of Chemical Technology, Tcirnaka, Hyderabad, Andhra Pradesh 500007, India [2]National Center for Mass Spectrometry,Indian Institute of Chemical Technology, Tarnaka, Hyderabad,Andhra Pradesh 500007, India

出　　处：《Journal of Pharmaceutical Analysis》2014年第6期399-406,共8页药物分析学报（英文版）

摘　　要：Polypill is a fixed-dose combination that contains three or more active ingredients used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects.A novel and accurate liquid chromatography tandem mass spectrometry method using electrospray ionization mode has been developed and validated for the simultaneous determination of amlodipine（AMD）,valsartan（VAL） using losartan（LOS） as an internal standard（IS）,and hydrochlorothiazide（HCT） using furosemide（FSD） as an IS.The separation was carried on Aquasil C18（50 mm×2.1 mm,5μm） reversed phase column using acetonitrile and water containing 0.1%formic acid（50：50,v/v） as the mobile phase.The method was validated in terms of linearity,accuracy and precision over the concentration range of 1-1000 ng/mL.The intra and inter-day precision and accuracy,stability and extraction recoveries of all the analytes were in the acceptable range.This method can be successfully applied to the pharmacokinetic study of AMD,VAL and HCT when given as a polypill.Polypill is a fixed-dose combination that contains three or more active ingredients used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects.A novel and accurate liquid chromatography tandem mass spectrometry method using electrospray ionization mode has been developed and validated for the simultaneous determination of amlodipine（AMD）,valsartan（VAL） using losartan（LOS） as an internal standard（IS）,and hydrochlorothiazide（HCT） using furosemide（FSD） as an IS.The separation was carried on Aquasil C18（50 mm×2.1 mm,5μm） reversed phase column using acetonitrile and water containing 0.1%formic acid（50：50,v/v） as the mobile phase.The method was validated in terms of linearity,accuracy and precision over the concentration range of 1-1000 ng/mL.The intra and inter-day precision and accuracy,stability and extraction recoveries of all the analytes were in the acceptable range.This method can be successfully applied to the pharmacokinetic study of AMD,VAL and HCT when given as a polypill.

关 键 词：AMLODIPINE VALSARTAN HYDROCHLOROTHIAZIDE Exforge HCT POLYPILL 

分 类 号：R969.1[医药卫生—药理学] O657.63[医药卫生—药学]