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Quantitative estimation of riluzole in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study

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Abstract

A novel simple, sensitive, selective, and rapid high-performance liquid chromatography coupled with tandem mass spectrometry method was developed and validated for quantification of riluzole in human plasma. The chromatography was performed by using a Zorbax-SB-C18 (4.6 × 75 mm, 3.5 μm) column , isocratic mobile phase 0.1% formic acid/acetonitrile (10:90 v/v), and an isotope-labeled internal standard (IS), [13C,15N2]riluzole. The extraction of drug and internal standard was performed by liquid–liquid extraction and analyzed by MS in the multiple reaction monitoring (MRM) mode using the respective [M+H]+ ions, m/z 235.0/165.9 for riluzole and m/z 238.1/169.0 for the IS. The calibration curve was linear over the concentration range 0.5–500.0 ng/ml for riluzole in human plasma. The limit of quantification (LOQ) was demonstrated at 0.5 ng/ml. The within-batch and between-batch precision were 0.6–2.3% and 1.4–5.7%, and accuracy was 97.1–101.1% and 98.8–101.2% for riluzole respectively. Drug and IS were eluted within 3.0 min. The validated method was successfully applied in a bioequivalence study of riluzole in human plasma.

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Acknowledgements

Authors wish to acknowledge IICT (Indian Institute of Chemical Technology), Hyderabad, India, for performing the literature survey and APL Research Centre, India, for providing clinical samples and supporting research work.

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Authors and Affiliations

  1. Faculty of Pharmacy, Al-Jabal Al-Gharbi University, P.O. Box 13040, Gherian, Libya

    Babu Rao Chandu

  2. Department of Pharmacy, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia

    Sreekanth Nama

  3. Nalanda Educational Society Kantepudi, Siddharth Institute of Pharmacy, Sattenapalli, Guntur, 522438, India

    Kanchanamala Kanala & Balasekhara Reddy Challa

  4. Adcock Ingram Limited, Bommasandra, Bangalore, 560099, India

    Rihana Parveen Shaik

  5. Jawaharlal Nehru Technological University, Hyderabad, 500081, India

    Sreekanth Nama & Mukkanti Khagga

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  1. Babu Rao Chandu
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  2. Sreekanth Nama
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  3. Kanchanamala Kanala
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  4. Balasekhara Reddy Challa
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  6. Mukkanti Khagga
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Correspondence to Babu Rao Chandu.

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Chandu, B.R., Nama, S., Kanala, K. et al. Quantitative estimation of riluzole in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study. Anal Bioanal Chem 398, 1367–1374 (2010). https://doi.org/10.1007/s00216-010-4034-8

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  • DOI: https://doi.org/10.1007/s00216-010-4034-8

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