• Daxesh P Patel, Primal Sharma, Mallika Sanyal, Puran Singhal, and Pranav S Shrivastav.
• Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, Gujarat, India.
• Biomed. Chromatogr. 2012 Dec 1; 26 (12): 1509-18.

AbstractAn ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the determination of nifedipine in human plasma using nifedipine-d6 as the internal standard (IS). The plasma samples were prepared by solid-phase extraction on Phenomenex Strata-X cartridges employing 200 μL human plasma. Chromatography was carried out on Waters Acquity UPLC BEH C₁₈ (50 × 2.1 mm, 1.7 µm particle size) analytical column under isocratic conditions using a mobile phase consisting of 4.0 mm ammonium acetate-acetonitrile (15:85, v/v). The precursor → product ion transitions for nifedipine (m/z 347.2 → 315.2) and IS (m/z 353.1 → 318.1) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive-ion mode. The method was validated over a wide dynamic concentration range of 0.050-150 ng/mL. Matrix effect was assessed by post-column analyte infusion and the mean extraction recovery was 95.6% across four quality control levels. The method is rugged and rapid with a total run time of 1.2 min and was applied to a bioequivalence study of 20 mg nifedipine tablet formulation in 30 healthy Indian subjects under fasting condition. Assay reproducibility was confirmed by reanalysis of 116 incurred samples.Copyright © 2012 John Wiley & Sons, Ltd.

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