Acetaminophen Analysis in Different Commercial Formulation of Iranian Acetaminophen Tablets Iranian Acetaminophen tablet analysis
Iranian Journal of Pharmaceutical Sciences,
Vol. 14 No. 4 (2018),
1 October 2018
,
Page 1-8
https://doi.org/10.22037/ijps.v14.40617
Abstract
Acetaminophen is one of the most important antipyretic and analgesic drugs. It has an excellent efficacy when it is used in therapeutic doses, but in unsafe doses it can be resulted in hepatotoxicity and permanent liver failure. Due to disparities that have been reported between the actual and stated concentration of acetaminophen tablets, we aimed to compare the actual quantity of 8 Iranian generic acetaminophen tablets with the stated amount on the label, using HPLC method. Drug concentration has been measured by HPLC. We performed USP procedure for all models such as tablets, capsule, and oral solution assay preparations USP-36 NF31 by standard preparations. Method validation was achieved. For USP guidelines performance we need to concern on standard references. By chromatography equipment, we used HPLC analyzer 1200 degasser, 1200 bin pump, 1200 ALS, and 1200 VWD. Acetaminophen sample solution included 325 mg weighted quantity of the powder that transferred to a 200 ml volumetric flask in addition to 100 ml of mobile phase. A part of this solution was transferred throughout a 0.5 micrometer permeable filter (or finer). By injecting 10 μL of standard solution into the chromatograph, major peaks are measured as a response. As a final point, calculation of the quantity of acetaminophen in each brand was obtained via specific formula. According to the USP, all brands consisted of 90.0– 110.0 % of the labeled amount of active ingredient (p<0.05). Consequently, The USP standards are met for drugs with different lot numbers by a variety of companies. The differences of clinical attributes of Paracetamol overdose between Iran and other countries may be related to pharmacokinetic and pharmacodynamics issues, metabolism, genetic factors or environmental effects. Further studies are recommended.
- Acetaminophen
- Analysis
- Generic tablets
- HPLC
- Paracetamol overdose
- Quality control
How to Cite
References
[2] Chun LJ, Tong MJ, Busuttil RW, Hiatt JR. Acetaminophen hepatotoxicity and acute liver failure. J. Clin. Gastroenterol. (2009) 43(4): 342-349.
[3] Lewis RK, Paloucek FP. Assessment and treatment of acetaminophen overdose. Clin. pharm. (1991) 10(10): 765-774. PMID: 1683827.
[4] McGill MR, Jaeschke H. Metabolism and disposition of acetaminophen: recent advances in relation to hepatotoxicity and diagnosis. J. Pharm. Res. (2013) 30(9): 2174-2187. PMID: 23462933.
[5] Jiang J, Briede JJ, Jennen DG, Van Summeren A, Saritas-Brauers K, Schaart G, et al. Increased mitochondrial ROS formation by acetaminophen in human hepatic cells is associated with gene expression changes suggesting disruption of the mitochondrial electron transport chain. Toxicol. Lett. (2015) 234(2):139-150. PMID: 25704631.
[6] Gilbert MT. High- performance liquid chromatography, 1ST ed., Elsevier: Butterworth- Heinemann (2013).
[7] Gerber F, Krummen M, Potgeter H, Roth A, Siffrin C, Spoendlin C. Practical aspects of fast reversed-phase high-performance liquid chromatography using 3μm particle packed columns and monolithic columns in pharmaceutical development and production working under current good manufacturing practice. J. Chromatogr. A. (2004) 1036(2): 127-133.
[8] Davignon JP, Trissel LA, Kleinman LM. Pharmaceutical assessment of amygdalin (Laetrile) products. Cancer. Treat. Rep. (1978) 62(1):99-104. PMID: 627001.
[9] Schwertner HA, Storrow AB. Comparison of actual and stated concentrations of pharmaceuticals manufactured in Mexico. Clin. Ther. (2005) 27(5): 609-615. PMID: 15978310.
[10] Josephy PD. Genetic variations in human glutathione transferase enzymes: significance for pharmacology and toxicology. Hum. Genomics. Proteomics. (2010) 2(1). PMID: 20981235
[11] Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, united states, 2010.JAMA. (2013) 309(7): 657-659. PMID: 23423407
[12] Lewis RK, Paloucek FP. Assessment and treatment of acetaminophen. Clin. pharm. (1991) 10: 765-774.
[13] McGill MR, Jaeschke H. Metabolism and disposition of acetaminophen: recent advances in relation to hepatotoxicity and diagnosis. J. Pharm. Res. (2013) 30(9): 2174-2187.
[14] Rosenberg J, Benowitz NL, Pond S. Pharmacokinetics of a drug overdose. Clin. pharmacokinet. (1981) 6(3): 161-192.
[15] Forrest JA, Clements J, Prescott L. Clinical pharmacokinetics of paracetamol. Clin. pharmacokinet. (1982) 7(2): 93-107.
[16] Ueshima Y, Tsutsumi M, Takase S, Matsuda Y, Kawahara H. Acetaminophen Metabolism in Patients with Different Cytochrome P‐4502E1 Genotypes. Alcohol. Clin. Exp. Res. (1996) 20(1suppl): 25a-28a. PMID: 8659683
[17] Critchley J, Nimmo G, Gregson C, Woolhouse N, Prescott L. Inter‐subject and ethnic differences in paracetamol metabolism. Br. J. Clin. Pharmacol. (1986) 22(6): 649-57.
[18] Zhao L, Pickering G. Paracetamol metabolism, and related genetic differences. Drug. Metab. Rev. (2011) 43(1): 41-52.
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