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Sensitive, selective and rapid determination of lafutidine in human plasma by solid phase extraction-liquid chromatography-tandem mass spectrometry

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Abstract

A simple, sensitive and high throughput liquid chromatography-tandem mass spectrometry method has been developed for the determination of lafutidine in human plasma. Sample clean-up involved solid phase extraction of lafutidine along with ranitidine as the internal standard from 100 μL of human plasma. The chromatographic separation is achieved within 2.5 min on a Grace Denali C18 (50 × 4.6 mm, 5 μ) column using 2 mM ammonium acetate, pH 3.0 adjusted with acetic acid and acetonitrile (20: 80, v/v) as the mobile phase. The precursor → product ion transitions for lafutidine (m/z 432.2 → 351.4) and IS (m/z 315.3 → 176.3) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive ion mode. The method is validated over a wide dynamic concentration range of 0.25–1000 ng/mL. The mean relative recovery for lafutidine across quality controls is 97.9%. The relative matrix effect between eight different plasma lots, expressed as coefficient of variation of the slopes of the calibration lines is 1.94. The method is applied to a bioequivalence study of 10 mg lafutidine tablet formulation in 26 healthy Indian male subjects under fasting condition. The reproducibility of study data is demonstrated by analysis of 93 incurred samples.

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Authors and Affiliations

  1. Bioanalytical Research Department, CRO, Cadila Pharmaceuticals Ltd., Ahmedabad, 387810, India

    M. Yadav, V. Trivedi, V. Upadhyay, G. Shah, H. Shah, A. Upadhyay & S. Goswami

  2. Department of Chemistry, School of Sciences, Gujarat University Navrangpura, Ahmedabad, 380009, India

    P. S. Shrivastav

Authors
  1. M. Yadav
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  2. V. Trivedi
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  3. V. Upadhyay
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  4. G. Shah
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  5. H. Shah
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  6. A. Upadhyay
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  7. S. Goswami
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  8. P. S. Shrivastav
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Yadav, M., Trivedi, V., Upadhyay, V. et al. Sensitive, selective and rapid determination of lafutidine in human plasma by solid phase extraction-liquid chromatography-tandem mass spectrometry. J Anal Chem 69, 448–460 (2014). https://doi.org/10.1134/S1061934814050116

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  • DOI: https://doi.org/10.1134/S1061934814050116

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