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Picogram Level Quantification of Grazoprevir and Elbasvir with Deuterated Internal Standards in Human Plasma Samples by LC–ESI-MS/MS

1, 2, 3

  1. 1Department of Chemistry, JNTUK, Kakinada-533003, India.
  2. 2Department of Chemistry, GITAM University, Visakhapatnam-530045, India.
  3. 3Department of Chemistry, Acharya Nagarjuna University, Nagarjuna nagar-522510, India.

CORRESPONDENCE

Haritha Potluri

Department of Chemistry, JNTUK, Kakinada-533003, India.

haritha.potluri@gmail.com

Received: 05-06-2016; Accepted: 14-09-2016.

Volume 50, Issue 4 · pp. 612-619 · 2016 · DOI: 10.5530/ijper.50.4.14

ABSTRACT

A fixed oral dose combination of grazoprevir and elbasvir is used for the treatment of patients with genotypes 1&4 HCV infections. In this manuscript, authors developed a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS) method used for quantification of grazoprevir and elbasvir in human plasma. Agilent TC-C18, 4.6 x 75 mm, 3.5 μm, 80 Å column, and 5 mM ammonium acetate: acetonitrile (20:80 v/v) mobilephase was used for Chromatographic separation. MRM positive mode was used to detect the grazoprevir and elbasvir at m/z 767.3/553.2, 883.4/656.3 respectively. Liquid-liquid extraction was employed in the extraction of analytes and internal standard from human plasma. This method is validated over a linear concentration range of 50.0 – 10000.0 pg/ml for grazoprevir and elbasvir. Calibration functions, lower limit of quantitation (LLOQ), stability, intra and inter-day reproducibility, accuracy, and recovery are estimated. Both drugs were stable in plasma samples. This method was free from matrix effects and any abnormal ionization.

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    Potluri, H., Battula, S. R., & Yeturu, S. (2016). Picogram Level Quantification of Grazoprevir and Elbasvir with Deuterated Internal Standards in Human Plasma Samples by LC–ESI-MS/MS. Indian Journal of Pharmaceutical Education and Research, 50(4), 612-619. https://doi.org/10.5530/ijper.50.4.14

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    © 2016 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0