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

A rapid and sensitive liquid chromatographyâtandem mass spectrometric (LCâMS/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 w...

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Main Authors: Vasu Babu Ravi, Jaswanth Kumar Inamadugu, Nageswara Rao Pilli, Vudagandla Sreenivasulu, Venkateswarlu Ponneri
Format: Article
Language:English
Published: Elsevier 2012-10-01
Series:Journal of Pharmaceutical Analysis
Online Access:http://www.sciencedirect.com/science/article/pii/S2095177912000482
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author Vasu Babu Ravi
Jaswanth Kumar Inamadugu
Nageswara Rao Pilli
Vudagandla Sreenivasulu
Venkateswarlu Ponneri
author_facet Vasu Babu Ravi
Jaswanth Kumar Inamadugu
Nageswara Rao Pilli
Vudagandla Sreenivasulu
Venkateswarlu Ponneri
author_sort Vasu Babu Ravi
collection DOAJ
description A rapid and sensitive liquid chromatographyâtandem mass spectrometric (LCâMS/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 cm3 (30 mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C18 column (50 mmÃ4.6 mm, 5 μm) using a mixture of acetonitrileâ5 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 (râ¥0.99) over the concentration range of 2.01â400.06 ng/mL for telmisartan and 0.05â10.01 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. Keywords: Telmisartan, Amlodipine, Human plasma, Solid-phase extraction, LCâMS/MS, Pharmacokinetics
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spelling doaj.art-c7ea4ec8c1f6499bb8cd8591ff339c512022-12-21T22:23:58ZengElsevierJournal of Pharmaceutical Analysis2095-17792012-10-0125319326Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic studyVasu Babu Ravi0Jaswanth Kumar Inamadugu1Nageswara Rao Pilli2Vudagandla Sreenivasulu3Venkateswarlu Ponneri4Research Studies, Rayalaseema University, Kurnool 518002, India; Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, IndiaWellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, IndiaWellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, IndiaBioPolymer and Thermophysical Lab, Department of Chemistry, Sri Venkateswara University, Tirupati 517502, IndiaAnalytical and Environmental Chemistry Division, Department of Chemistry, Sri Venkateswara University, Tirupati 517502, India; Corresponding author. Tel.: +91 9393600444.A rapid and sensitive liquid chromatographyâtandem mass spectrometric (LCâMS/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 cm3 (30 mg) extraction cartridge. The reconstituted samples were chromatographed on a Hypurity advance C18 column (50 mmÃ4.6 mm, 5 μm) using a mixture of acetonitrileâ5 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 (râ¥0.99) over the concentration range of 2.01â400.06 ng/mL for telmisartan and 0.05â10.01 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. Keywords: Telmisartan, Amlodipine, Human plasma, Solid-phase extraction, LCâMS/MS, Pharmacokineticshttp://www.sciencedirect.com/science/article/pii/S2095177912000482
spellingShingle Vasu Babu Ravi
Jaswanth Kumar Inamadugu
Nageswara Rao Pilli
Vudagandla Sreenivasulu
Venkateswarlu Ponneri
Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
Journal of Pharmaceutical Analysis
title Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
title_full Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
title_fullStr Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
title_full_unstemmed Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
title_short Simultaneous determination of telmisartan and amlodipine in human plasma by LCâMS/MS and its application in a human pharmacokinetic study
title_sort simultaneous determination of telmisartan and amlodipine in human plasma by lcams ms and its application in a human pharmacokinetic study
url http://www.sciencedirect.com/science/article/pii/S2095177912000482
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