Journal: Inter. J. of Chemical and Analytical Science

Article Id: JPRS-PC-00001162
Title: A new, simple and rapid method for simultaneous determination of ethambutol and isoniazid in dried blood spots by LC-MS/MS and its application to pharmacokinetic study.
Category: Pharmaceutical Chemistry
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    Background: Ethambutol (EMB) and isoniazid (INH) are first-line anti tubercular drugs. The combination formulation is used for the continuation phase of tuberculosis. A new, simple and rapid method for simultaneous determination of ethambutol and isoniazid in dried blood spots (DBS) was developed and validated using LC-MS/MS. This method was successfully applied to pharmacokinetic study following oral administration of tablet of fixed dose combination containing ethambutol hydrochloride 800 mg and isoniazid 300 mg in human volunteers. Methods: Whole blood samples were spotted, dried and a 3 mm punch was extracted with methanol. The separation was performed on kromasil C18 column (150×4.6mm i.d., 5µm particle size) using a mobile phase composed of 0.1% formic acid in water and methanol (35:65 v/v) at a flow rate of 0.8 mL/min. The total run time was 3.5 min with retention times of 1.34 min for EMB, 1.90 for INH and 2.44 for IS. Results: The method was linear over the concentration range of 50-4000 ng/mL for EMB and 100-5500 ng/mL for INH with all correlation coefficients greater than 0.9943 and 0.9941 for EMB and INH respectively. The intra-day accuracy of the method was ranged from 95.5% to 103.4% and the inter-day accuracy was between 97.8% and 103.8% with the precision less than 8.4 and 7.5% respectively. The stability of both the analytes was evaluated under various conditions. Conclusion: The method described here was validated in accordance with “Guidance for industry: Bioanalytical method validation, USFDA (2001)” and the method was successfully applied to the pharmacokinetic study after oral administration. DBS technique has been demonstrated to produce similar PK profiles as that of plasma quantitation methods, supporting the use of DBS as an alternative for plasma pharmacokinetic studies.

    Cite this article as: P Pavan Kumar, T E G K Murthy,A new, simple and rapid method for simultaneous determination of ethambutol and isoniazid in dried blood spots by LC-MS/MS and its application to pharmacokinetic study,International Journal of Chemical and Analytical Science 2014,5(1),49-54.

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  • About the authors and Affiliations

    Author(s) Name:

    P Pavan Kumara,*, T E G K Murthyb

    Affiliation(s) Name:

    aKrishna University, Machilipatnam, Andhra Pradesh 521001, India.
    bBapatla College of Pharmacy, Bapatla, Guntur District, Andhra Pradesh 522101, India.


    *Corresponding author.
    P Pavan Kumar
    Krishna University, Machilipatnam,
    Andhra Pradesh 521001, India.


    Received on: 17-12-2013; Revised on: 29-12-2013; Accepted on:31-01-2014

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    Author:

    P Pavan Kumara,*, T E G K Murthyb

    Title:A new, simple and rapid method for simultaneous determination of ethambutol and isoniazid in dried blood spots by LC-MS/MS and its application to pharmacokinetic study.
    Journal:Inter. J. of Chemical and Analytical Science
    Vol(issue):6 (January)
    Year:2015
    Page No: (0-0)
  • Experimental Methods Keywords

    Methodology:Tandem Mass Spectrometry,Validation,pharmacokinetic study
    Research Materials:ethambutol and isoniazid

Keywords

Tandem Mass Spectrometry Tuberculosis Validation Ethambutol Isoniazid

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