Simultaneous determination of telmisartan and amlodipine in human plasma by LC-MS/MS and its application in a human pharmacokinetic study

查看全文 作　　者：Vasu Babu [1,2]Ravi;Jaswanth Kumar [2]Inamadugu;Nageswara Rao [2]Pilli;Vudagandla [3]Sreenivasulu;Venkateswarlu [4]Ponneri

机构地区：[1]Research Studies,Rayalaseema University,Kurnool 518002,India;[2]Wellquest Clinical Research Laboratories,Ramanthapur,Hyderabad 500013,India;[3]BioPolymer and Thermophysical Lab,Department of Chemistry,Sri Venkateswara University,Tirupati 517502,India;[4]Analytical and Environmental Chemistry Division,Department of Chemistry,Sri Venkateswara University,Tirupati 517502,India

出　　处：《Journal of Pharmaceutical Analysis》索引2012年第2卷第5期,共8页

摘　　要：A rapid and sensitive liquid chromatography-tandem mass spectrometric(LC-MS/MS) assay method has been developed and fully validated for the simultaneous quantification of telmisartan and amlodipine in human plasma.Carbamazepine was used as an internal standard.Analytes and the internal standard were extracted from human plasma by solid-phase extraction technique using Waters Oasis  HLB 1 cm 3(30 mg) extraction cartridge.The reconstituted samples were chromatographed on a Hypurity advance C 18 column(50 mm×4.6 mm,5 μm) using a mixture of acetonitrile-5 mM ammonium acetate buffer(pH-4.0)(50:50,v/v) as the mobile phase at a flow rate of 0.8 mL/min.The calibration curve obtained was linear(r≥0.99) over the concentration range of 2.01-400.06 ng/mL for telmisartan and 0.05-10.01 ng/mL for amlodipine.Method validation was performed as per FDA guidelines and the results met the acceptance criteria.A run time of 2.5 min for each sample made it possible to analyze more than 400 human plasma samples per day.The proposed method was found to be applicable to clinical studies. 关键词：LC-MS MS 高效液相色谱法氨氯地平替米沙坦人血浆药代动力学同时测定应用

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Simultaneous determination of telmisartan and amlodipine in human plasma by LC-MS/MS and its application in a human pharmacokinetic study

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