Low dose aspirin estimation: an application to a human pharmacokinetic study |
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Authors: | D. Vijaya Bharathi Kishore Kumar Hotha Pandu Ranga Reddy Kolagatla V. Venkateswarlu |
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Affiliation: | Bioanalytical Department, Integrated Product Development, Dr Reddy's Laboratories Ltd, Bachupalli, , Hyderabad‐500 072, India |
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Abstract: | Low dose to very high dose aspirin is used to prevent heart attack. We have developed and validated a sensitive and robust method that could detect low levels of aspirin and salicylic acid in plasma and also a novel sample collection procedure to carry out sample preparation at room temperature. The total run time was 3.00 min; the developed method was validated in human plasma with a lower limit of quantitation of 0.99 ng/mL for aspirin and 2.01 ng/mL for salicylic acid. A linear response function was established for the range of concentrations 0.99–756.20 ng/mL (r > 0.998) for aspirin and 2.01–2486.86 ng/mL for salicylic acid. The intra‐ and inter‐day precision values for aspirin and salicylic acid met the acceptance as per FDA guidelines. The developed assay method was applied to an oral pharmacokinetic study in humans. Copyright © 2012 John Wiley & Sons, Ltd. |
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Keywords: | aspirin salicylic acid LC‐MS/MS method validation human plasma pharmacokinetics |
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