Low dose aspirin estimation: an application to a human pharmacokinetic study.
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.
Bioanalytical Department, Integrated Product Development, Dr Reddy's Laboratories Ltd, Bachupalli, Hyderabad-500 072, India. vijayabd@drreddys.com
D
D
Vijaya Bharathi
Kishore Kumar
KK
Hotha
Pandu Ranga Reddy
PR
Kolagatla
V
V
Venkateswarlu
D000284:Administration, Oral; D001241:Aspirin / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D004305:Dose-Response Relationship, Drug; D004355:Drug Stability; D006801:Humans; D057230:Limit of Detection; D008297:Male; D015203:Reproducibility of Results; D020156:Salicylic Acid / Q000097:blood / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry
D020156:Salicylic Acid; D001241:Aspirin