Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies

A validated ultra-performance liquid chromatography mass spectrometric method (UPLCâMS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma. The analysis was performed on UPLCâMS/MS system using turbo ion spray interface. Negative ions were...

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Main Authors: Bhupinder Singh, Rama S. Lokhandae, Ashish Dwivedi, Sandeep Sharma, Naveen Dubey
Format: Article
Language:English
Published: Elsevier 2014-04-01
Series:Journal of Pharmaceutical Analysis
Online Access:http://www.sciencedirect.com/science/article/pii/S2095177913000579
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author Bhupinder Singh
Rama S. Lokhandae
Ashish Dwivedi
Sandeep Sharma
Naveen Dubey
author_facet Bhupinder Singh
Rama S. Lokhandae
Ashish Dwivedi
Sandeep Sharma
Naveen Dubey
author_sort Bhupinder Singh
collection DOAJ
description A validated ultra-performance liquid chromatography mass spectrometric method (UPLCâMS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma. The analysis was performed on UPLCâMS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM) mode. The analytes were extracted using a liquidâliquid extraction (LLE) method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mmÃ4.6 mm, 5 µm) column with organic mixture:buffer solution (80:20, v/v) at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC) and HCT immediate release tablets with reference product in human subjects. Keywords: Candesartan cilexetil, Hydrochlorothiazide, UPLCâMS/MS, Bioequivalence, Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT)
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spelling doaj.art-87f0dca25ebb48008337523dcbaba8c72022-12-21T22:02:26ZengElsevierJournal of Pharmaceutical Analysis2095-17792014-04-0142144152Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studiesBhupinder Singh0Rama S. Lokhandae1Ashish Dwivedi2Sandeep Sharma3Naveen Dubey4Jubiliant Clinsys Limited, Noida, New Delhi, IndiaJaipur National University, Jaipur, IndiaJubiliant Clinsys Limited, Noida, New Delhi, IndiaJubiliant Clinsys Limited, Noida, New Delhi, IndiaJubiliant Clinsys Limited, Noida, New Delhi, IndiaA validated ultra-performance liquid chromatography mass spectrometric method (UPLCâMS/MS) was used for the simultaneous quantitation of candesartan (CN) and hydrochlorothiazide (HCT) in human plasma. The analysis was performed on UPLCâMS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM) mode. The analytes were extracted using a liquidâliquid extraction (LLE) method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mmÃ4.6 mm, 5 µm) column with organic mixture:buffer solution (80:20, v/v) at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC) and HCT immediate release tablets with reference product in human subjects. Keywords: Candesartan cilexetil, Hydrochlorothiazide, UPLCâMS/MS, Bioequivalence, Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT)http://www.sciencedirect.com/science/article/pii/S2095177913000579
spellingShingle Bhupinder Singh
Rama S. Lokhandae
Ashish Dwivedi
Sandeep Sharma
Naveen Dubey
Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
Journal of Pharmaceutical Analysis
title Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
title_full Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
title_fullStr Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
title_full_unstemmed Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
title_short Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLCâMS/MS and its application in bioequivalence studies
title_sort improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by uplcams ms and its application in bioequivalence studies
url http://www.sciencedirect.com/science/article/pii/S2095177913000579
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