Quantitative Determination of Topiramate in Human Serum and Umbilical Cord Blood

Author(s): Cristina Cifuentes, Sigrid Mennickent*, Marta De Diego

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 5 , 2019


Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


Abstract:

Background: Topiramate (TPM), an anticonvulsant drug, was determined in human serum and in umbilical cord blood. TPM can produce severe damage to the fetus (baby into mother´s uterus), and it is not always possible that epileptic women change their drug during pregnancy, because some antiepileptic drugs are not effective on some people. Using pregnant-mother serum blood, we can estimate drug levels in fetus serum, and by umbilical cord blood, is possible estimate drug levels in serum babies, without the ethic aspects to withdrawal blood of them.

Methods: Quantitation was achieved by LC/DAD, using liquid-liquid extraction for isolation of TPM from both biological fluids, using dichloromethane as extraction solvent, and dabsyl chloride as derivatizing agent.

Results: The method was linear over the concentration range of 5.0 to 20.0 µg/mL for TPM in human serum, and between 1.6-50.0 µg/mL for TPM in umbilical cord blood (r=0.999 and r= 0.998, respectively). RSD, for intra-assay study, was between 0.64%- 1.22% (n=3), and between 0.57% -1.86% (n=9) for inter-assay, when the biological fluid was human serum, and between 0.33% - 3.44%, and 3.38% -3.73%, respectively, when the matrix was umbilical cord blood. LOD was 0.40 µg/mL and 0.39 μg/mL for TPM in human serum and in umbilical cord, respectively, whereas LOQ was 1.20 µg/mL and 1.18 μg/mL, in each biological fluid. Recovery percentage for the accuracy study was between 94.0% and 109.8% (RSD ≤0.191).

Conclusion: The method is precise, accurate, reproducible and selective for level analysis of TPM in both matrices.

Keywords: Topiramate, antiepileptics, human serum, umbilical cord, liquid chromatography, fetal risk.

[1]
Summary of Product Characteristics - Topamax® 15 mg 25 mg 50 mg tablets (topiramate). Ortho-McNeil-Janssen Pharmaceuticals Inc 2009.
[2]
Sachdeo, R.C. Topiramate Clinical profile in epilepsy. Clin. Pharmacokinet., 1998, 34, 335-346.
[3]
Glauser, T.A.; Levisohn, P.M.; Ritter, F.; Sachdeo, R.C. Topiramate in Lennox-Gastaut syndrome: open-label treatment of patients completing a randomized controlled trial. Epilepsia, 2000, 41(Suppl. 1), S86-S90.
[4]
Kugler, S.L.; Sachdeo, R.C. Topiramate efficacy in infancy. Ped. Neurol., 1998, 19, 320-322.
[5]
Huang, W.Y.; Lo, M.C.; Wang, S.J.; Tsai, J.J.; Wu, H.M. Topiramate in prevention of cluster headache in the Taiwanese. Neurol. India, 2010, 58, 284-287.
[6]
Kanemura, H.; Sano, F.; Tando, T.; Sugita, K.; Aihara, M. Effects of topiramate on headache in children with epilepsy. Brain Dev., 2015, 47, 18-22.
[7]
Sahraian, A.; Bigdeli, M.; Ghanizadeh, A.; Akhondzadeh, S. Topiramate as an adjuvant treatment for obsessive compulsive symptoms in patients with bipolar disorder: a randomized double blind placebo controlled clinical trial. J. Affect. Disord., 2014, 166, 201-205.
[8]
Correll, C.U.; Sheridan, E.M.; Del Bello, M.P. Antipsychotic and mood stabilizer efficacy and tolerability in pediatric and adult patients with bipolar I mania: a comparative analysis of acute, randomized, placebo-controlled trials. Bipolar Disord., 2010, 12, 116-141.
[9]
Alfaris, N.; Minnick, A.M.; Hopkins, C.M.; Berkowitz, R.I.; Wadden, T.A. Combination phentermine and topiramate extended release in the management of obesity. Expert Opin. Pharmacother., 2015, 16, 1263-1274.
[10]
Wiffen, P.J.; Derry, S.; Lunn, M.P.; Moore, R.A. Topiramate for neuropathic pain and fibromyalgia in adults. CDSR, 2013, 8, CD008314.
[11]
Chiaro, G.; Caletti, M.T.; Provini, F. Treatment of sleep-related eating disorder. Curr. Treat. Options Neurol., 2015, 17, 361.
[12]
Guglielmo, R.; Martinotti, G.; Quatrale, M.; Ioime, L.; Kadilli, I.; Di Nicola, M.; Janiri, L. Topiramate in alcohol use disorders: review and update. CNS Drugs, 2015, 29, 383-395.
[13]
Hammond, C.J.; Niciu, M.J.; Drew, S.; Arias, A.J. Anticonvulsants for the treatment of alcohol withdrawal syndrome and alcohol use disorders. CNS Drugs, 2015, 29, 293-311.
[14]
Khazaal, Y.; Zullino, D.F. Topiramate for smoking cessation and the importance to distinguish withdrawal-motivated consumption and cue-triggered automatisms. J. Clin. Psychopharmacol., 2009, 29, 192-193.
[15]
Oncken, C.; Arias, A.J.; Feinn, R.; Litt, M.; Covault, J.; Sofuoglu, M.; Kranzler, H.R. Topiramate for smoking cessation: a randomized, placebo-controlled pilot study. Nicotine Tob. Res., 2014, 16, 288-296.
[16]
Reid, M.S.; Palamar, J.; Raghavan, S.; Flammino, F. Effects of topiramate on cue-induced cigarette craving and the response to a smoked cigarette in briefly abstinent smokers. Psychopharmacol, 2007, 192, 147-158.
[17]
Hardman, J.; Limbird, L. Las Bases Farmacológicas de la Terapéutica; Mc Graw-Hill: Mexico, 2006.
[18]
Mc Evoy, G. AHFS Drug Information; American Society of Health-System Pharmacists: Bethesda, 2012.
[19]
Sweetman, S. Martindale. Guía Completa de Consulta Farmacoterapéutica, Barcelona: Pharma Editores S.L. 2006.
[20]
Guerrini, R.; Parmeggiani, L. Topiramate and its clinical applications in epilepsy. Expert Opin. Pharmacother., 2006, 7, 811-823.
[21]
Bahrami, G.; Mirzaeei, S.; Mohammadi, B.; Kiani, A. High performance liquid chromatographic determination of topiramate in human serum using UV detection. J. Chromatogr. B Biomed. Sci. Appl., 2005, 822, 322-325.
[22]
Walker, R.B.; Mohammadi, A.; Rezanour, N.; Ansari, M. Development of a stability-indicating high performance liquid chromatographic method for the analysis of topiramate and dissolution rate testing in topiramate tablets. Asian J. Chem., 2010, 22, 3856-3866.
[23]
Styslo-Zalasik, M.; Li, W. Determination of topiramate and its degradation product in liquid oral solutions by high performance liquid chromatography with a chemiluminescent nitrogen detector. J. Pharm. Biomed. Anal., 2005, 37, 529-534.
[24]
Jalili, R.; Majnooni, M.B.; Mohammadi, B.; Fakhri, S.; Mirzaei, S.; Ahmadi-Jouibari, T.; Bahrami, G. Development and validation of a new method for determination of topiramate in bulk and pharmaceutical formulation using high performance liquid chromatography UV detection after precolumn derivatization. J. Rep. Pharmaceut. Sci., 2014, 3, 179-183.
[25]
Mandrioli, R.; Musenga, A.; Kenndler, E.; De Donno, M.; Amore, M.; Raggi, M.A. Determination of topiramate in human plasma by capillary electrophoresis with indirect UV detection. J. Pharm. Biomed. Anal., 2010, 53, 1319-1323.
[26]
Roskar, R.; Milosheska, D.; Vovk, T.; Grabnar, I. Simple and sensitive high performance liquid chromatography method with fluorescence detection for therapeutic drug monitoring of topiramate. Acta Chim. Slov., 2015, 62, 411-419.
[27]
Bahrami, G.; Mohammadi, B. A novel high sensitivity HPLC assay for topiramate, using 4-chloro-7-nitrobenzofurazan as pre-column fluorescence derivatizing agent. J. Chromatogr. B Biomed. Sci. Appl., 2007, 850, 400-404.
[28]
Bahrami, G.; Mirzaeei, S.; Kiani, A. Sensitive analytical method for Topiramate in human serum by HPLC with pre-column fluorescent derivatization and its application in human pharmacokinetic studies. J. Chromatogr. B Biomed. Sci. Appl., 2004, 813, 175-180.
[29]
Contin, M.; Riva, R.; Albani, F.; Baruzzi, A. Simple and rapid liquid chromatographic-turbo ion spray mass spectrometric determination of topiramate in human plasma. J. Chromatogr. B Biomed. Sci. Appl., 2001, 761, 133-137.
[30]
Mercolini, L.; Mandrioli, R.; Amore, M.; Raggi, M.A. Simultaneous HPLC-F analysis of three recent antiepileptic drugs in human plasma. J. Pharm. Biomed. Anal., 2010, 53, 62-67.
[31]
Popov, T.V.; Maricic, L.C.; Prosen, H.; Voncina, D.B. Determination of topiramate in human plasma using liquid chromatography tandem mass spectrometry. Acta Chim. Slov., 2013, 60, 144-150.
[32]
Deeb, S.; Mc Keown, D.; Orrance, H.; Wylie, F.; Logan, B.; Scott, K. Simoultaneous analysis of 22 antiepileptic drugs in postmortem blood, serum and plasma using LC-MS-MS with a focus on their role in forensic cases. J. Anal. Toxicol., 2014, 38, 485-494.
[33]
Carlow, D.C.; Shi, H.; Schofield, R.C. Simultaneous quantitation of lamotrigine, levetiracetam, 10-hydroxycarbazepine, topiramate and zonisamide in serum using HPLC MS/MS Methods. Mol. Biol., 2016, 1383, 29-37.
[34]
Kuchekar, S.R.; Zaware, B.H.; Kundlik, M.L. Rapid and specific approach for direct measurement of topiramate in human plasma by LC-MS/MS: application for bioequivalence study. J. Bioanal. Biomed., 2010, 2, 107-112.
[35]
Mennickent, S.; Cifuentes, C.; De Diego, M. Quantitative determination of topiramate in human breast milk. J. Anal. Bioanal. Tech., 2016, 7, 1-5.
[36]
Popov, T.V.; Maricic, L.C.; Prosen, H.; Voncina, D.B. Determination of topiramate in human plasma using liquid chromatography tandem mass spectrometry. Acta Chim. Slov., 2013, 60, 144-150.
[37]
Mandrioli, R.; Musenga, A.; Kenndler, E.; De Donno, M.; Amore, M.A. Raggi, Determination of topiramate in human plasma by capillary electrophoresis with indirect UV detection. J. Pharm. Anal., 2010, 53, 1319-1323.
[38]
Bahrami, S.; Mirzaeei, A.; Kiani, M. Sensitive analytical method for Topiramate in human serum by HPLC with pre-column fluorescent derivatization and its application in human pharmacokinetic studies. J. Chromatogr. B Biomed. Sci. Appl., 2004, 813, 175-180.
[39]
Contin, M.; Riva, R.; Albani, F.; Baruzzi, A. Simple and rapid liquid chromatographic-turbo ion spray mass spectrometric determination of topiramate in human plasma. J. Chromatogr. B Biomed. Sci. Appl., 2001, 761, 133-137.
[40]
Zarrin, E.H. Photodiode Array Detection in Clinical Applications. In: Quantitative Analyte Assay Advantages, Limitations and Disadvantages; Photodiodes - Communications, Bio-Sensings, Measurements and High-Energy Physics; 1st ed. Croacia: Intech 2011.
[41]
The Sixth ICH International Conference on Armonization of Technical for Registration of Pharmaceuticals for Human Use, Osaka,. 2003.
[42]
The United States Pharmacopeia (USP30)., Rocville: United States Pharmacopeial Convection, Inc. 2007.
[43]
Milosheska, D.; Vovk, T.; Grabnar, I.; Roskar, R. Simple and Sensitive High Performance Liquid Chromatography Method with Fluorescence Detection for Therapeutic Drug Monitoring of Topiramate. Acta Chim. Slov., 2015, 62, 411-419.


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 15
ISSUE: 5
Year: 2019
Published on: 23 May, 2019
Page: [521 - 527]
Pages: 7
DOI: 10.2174/1573412914666180502124419
Price: $65

Article Metrics

PDF: 39
HTML: 4