AN IMPROVED MICROMETHOD FOR THE DETERMINATION OF ACETAMINOPHEN IN PLASMA BY VISIBLE SPECTROPHOTOMETRY: APPLICATION TO A PHARMACOKINETIC STUDY IN RABBITS

Authors

  • Jose Raul Medina Departamento Sistemas Biologicos Universidad Autonoma Metropolitana-Xochimilco
  • Adela Licea Departamento Sistemas Biologicos Universidad Autonoma Metropolitana-Xochimilco
  • Marcela Hurtado Departamento Sistemas Biologicos Universidad Autonoma Metropolitana-Xochimilco

DOI:

https://doi.org/10.22159/ijap.2017v9i4.19246

Keywords:

Acetaminophen, NSAIDs, Pharmacokinetics, Rabbits, Spectrophotometric determination

Abstract

Objective: To report a simple and economic alternative spectrophotometric micro-method for the determination of acetaminophen using 200 µl of plasma sample.

Methods: The analyses were based on a simple colorimetric test in which p-aminophenol, after an acidic hydrolysis step, is reacted with phenol in an alkaline medium to form an indophenol dye which exhibits a maximum extintion at 625 nm. The micro method was validated according to the international criteria, and then it was used for the quantification of plasma levels of acetaminophen after rectal administration of 100 mg of the drug to male New Zealand rabbits.

Results: The analytical recovery was 100.97%, with solutions of 5−25 µg/ml (plasma/water). The linearity with plasma solutions was good (R2 = 0.995), at the same concentration levels. The within-run and between-run precision, as well as accuracy expressed as coefficient of variation, were less than 8%. The mean accuracy was 102.24%. The stability was proved for a one-week period at −20 °C. The pharmacokinetic parameters were computed by non-linear regression analysis. The non-compartment model analysis was used to fit the in vivo data.

Conclusion: The validation parameters were within acceptable limits for clinical studies. The analysis was adequate for the determination of acetaminophen in small plasma samples, and it can be easily adapted by any hospital or clinical laboratory with non-special equipment.

 

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References

Gyamlani GG, Parik CR. Acetaminophen toxicity: suicidal vs accidental. Crit Care 2002;6:155−9.

Van Bocxlaer JF, Clauwaert KM, Lambert WE, De Leenheer AP. Quantitative colorimetric determination of urinary p-aminophenol with an automated analyzer. Clin Chem 1997;43:627−34.

Frings CS, Saloom JM. Colorimetric method for the quantitative determination of acetaminophen in serum. Clin Toxicol 1979;15:67−73.

Liu TZ, Oka KH. Spectrophotometric screening method for acetaminophen in serum and plasma. Clin Chem 1980;26:69−71.

O´Connell SE, Zurzola FJ. A rapid quantitative determination of acetaminophen in plasma. J Pharm Sci 1982;71:1291−4.

Bailey ON. Colorimetry of serum acetaminophen (paracetamol) in uremia. Clin Chem 1982;28:187−90.

Koren G. Therapeutic drug monitoring principles in the neonate. Clin Chem 1997;43:222−7.

El-Didamoni AM, Hafeez SH, Saad AA. Extraction-spectrophotometric determination of some antihypertensive drugs in pharmaceuticals and biological fluids using two sulphonphthalein dyes. Int J Appl Pharm 2015;7:10−7.

Bouchaib I, Mohamed S, El Mestafa EH, Sanae A, Taoufiq S. A statistical approach based on the total error concept for validation the bioanalytical method: application to the spectrophotometric determination of traces amount of acetaminophen in human plasma. Int J Pharm Pharm Sci 2014;6:413−21.

Dadhaniya T, Chaudhary K, Mehta P. Development of LC-MS method for determination of iloperidone in rabbit plasma: application to a pharmacokinetic study. Int J Pharm Pharm Sci 2015;7:294−7.

Coulthard KP, Nielson HW, Schroder M, Covino A, Matthews NT, Murray RS, et al. Relative bioavailability and plasma paracetamol profiles of panadol suppositories in children. Aust Paediatr J 1998;34:425−31.

Birmingham PK, Tobin MJ, Henthorn TK, Fischer DM, Berkelhamer MC, Smith FA, et al. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology 1997; 87:244−52.

U. S. Food and Drug Administration. Guidance for Industry. Bioanalytical Method Validation; 2013. Available from: https://www.fda.gov/downloads/Drugs/Guidances/ucm368107.pdf. [Last accessed on 16 Apr 2017]

Rosing H, Man WY, Doyle E, Bult A, Beijen JH. Bioanalytical liquid chromatographic method validation. A review of current practices and procedures. J Liq Chromatogr Relat Technol 2000;23:329−54.

NORMA Official Mexicana NOM-062-ZOO-1999. Especificaciones técnicas para la producción, cuidado y uso de los animales de laboratorio; 1999. Available from: http://www.ibt.unam.mx/computo/pdfs/bioterio.NOM-062.pdf. [Last accessed on 16 Apr 2017]

Tanaka Y, Kotaki H, Nakamura H, Uchino K, Iga T. Change of pharmacokinetic behavior of acetaminophen after discharge of suppository from rectum rabbits. Jpn J Hosp Pharm 1994;20:294−301.

Published

13-07-2017

How to Cite

Medina, J. R., Licea, A., & Hurtado, M. (2017). AN IMPROVED MICROMETHOD FOR THE DETERMINATION OF ACETAMINOPHEN IN PLASMA BY VISIBLE SPECTROPHOTOMETRY: APPLICATION TO A PHARMACOKINETIC STUDY IN RABBITS. International Journal of Applied Pharmaceutics, 9(4), 96–98. https://doi.org/10.22159/ijap.2017v9i4.19246

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