Sensitive and selective liquid chromatography–tandem mass spectrometry method for the determination of metoclopramide in human plasma: application to a bioequivalence study |
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| Authors: | Jaswanth Kumar Inamadugu Rajasekhar Damaramadugu Ramesh Mullangi Venkateswarlu Ponneri |
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| Affiliation: | 1. Analytical and Environmental Chemistry Division, Department of Chemistry, Sri Venkateswara University, Tirupati‐517 502, India;2. Bioanalytical Division, Wellquest Clinical Research Laboratory, Hyderabad‐500 013, India;3. Jubilant Innovation, 96, Industrial Suburb, 2nd stage, Yeshwanthpur, Bangalore‐560 022, India |
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| Abstract: | A simple, sensitive and rapid method has been developed and validated for determination of the metoclopramide (MCP) in 100 μL human plasma. The analytical procedure involves a liquid–liquid extraction method using tramadol as an internal standard (IS). Chromatographic separation was carried out on a HyPURITY ADVANCE column using a mobile phase consisting of acetonitrile and 10 mm ammonium acetate buffer in the ratio of 80:20 (v/v) at a flow rate of 0.3 mL/min. The total run time of analysis was 2.5 min and elution of MCP and IS occurred at 0.9 and 1.3 min, respectively. A linear response function was established for the range of concentrations 0.53–42.07 ng/mL (r > 0.99). The intra‐ and inter‐day precision values for MCP met the acceptance as per FDA guidelines. MCP was stable in a battery of stability studies viz., bench‐top, auto‐sampler and freeze–thaw cycles. The developed assay method was successfully applied to an oral bioequivalence study in humans. Copyright © 2010 John Wiley & Sons, Ltd. |
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| Keywords: | metoclopramide LC‐MS/MS method validation human plasma pharmacokinetics |
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