Validated HPLC method for concurrent determination of antipyrine, carbamazepine, furosemide and phenytoin and its application in assessment of drug permeability through Caco-2 cell monolayers

Scientia Pharmaceutica

Volumn 80, Issue 1, 2012, Pages 89-100

  Patil, Sachin Ramrao ^a   Kumar, Lokesh ^a   Kohli, Gunjan ^a   Bansal, Arvind Kumar ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Caco 2 cell monolayer; Carbamazepine; Furosemide; HPLC; Phenazone; Phenytoin; Validation

Indexed keywords

ACETONITRILE; CARBAMAZEPINE; FUROSEMIDE; METHANOL; PHENAZONE; PHENYTOIN; WATER;

ACCURACY; ARTICLE; CELL STRAIN CACO 2; CONTROLLED STUDY; DRUG DETERMINATION; DRUG PENETRATION; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PH; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; TEMPERATURE; VALIDATION STUDY;

EID: 84857946282     PISSN: 00368709     EISSN: 22180532     Source Type: Journal    
DOI: 10.3797/scipharm.1109-03     Document Type: Article

References (25)

1. Artursson P, Karlsson J. Correlation between oral drug absorption in humans and apparent drug permeability coefficient in human intestinal epithelial (Caco-2) cells. Biochem Biophys Res Commun. 1991; 175: 880-885. http://dx.doi.org/10.1016/0006-291X(91)91647-U
2. U.S. Department of Health and Human Services. FDA, Center for Drug Evaluation and Research (CDER). Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. US FDA Guidance for Industry. 2000; 1-16.
3. van Breemen RB, Li Y. Caco-2 cell permeability assays to measure drug absorption. Expert Opin Drug Metabol Toxicol. 2005; 1: 175-185. http://dx.doi.org/10.1517/17425255.1.2.175
4. Volpe DA, Faustino PJ, Ciavarella AB, Asafu-Adjaye EB, Ellison CD, Yu LX, Hussain AS. Classification of drug permeability with a Caco-2 cell monolayer assay. Clin Res Regul Aff. 2007; 24: 39-47. http://dx.doi.org/10.1080/10601330701273669
5. Chawla S, Ghosh S, Sihorkar V, Nellore R, Kumar TR, Srinivas NR. High-performance liquid chromatography method development and validation for simultaneous determination of five model compounds, antipyrine, metoprolol, ketoprofen, furosemide and phenol red, as a tool for the standardization of rat in situ intestinal permeability studies using timed wavelength detection. Biomed Chromatogr. 2006; 20: 349-357. http://dx.doi.org/10.1002/bmc.570
6. Eichelbaum M, Sonntag B, Dengler HJ. HPLC Determination of Antipyrine Metabolites. Int J Exp Clin Pharmacol. 1981; 23: 192-202. http://dx.doi.org/10.1159/000137550
7. Weber A, Opheim K, Smith AL. Simplified high performance liquid chromatographic quantitation of antipyrine. J Chromatogr Sci. 1984; 22: 239-240. http://www.ncbi.nlm.nih.gov/pubmed/6746839
8. Drummer O, Morris P, Vajda F. Plasma carbamazepine determinations: a simple gas chromatographic method. Clin Exp Pharmacol Physiol. 1976; 3: 497-501. http://dx.doi.org/10.1111/j.1440-1681.1976.tb00629.x
9. Franceschi L, Furlanut M. A simple method to monitor plasma concentrations of oxcarbazepine, carbamazepine, their main metabolites and lamotrigine in epileptic patients. Pharmacol Res. 2005; 51: 297-302. http://dx.doi.org/10.1016/j.phrs.2004.09.008
10. Furlanut M, Delucca MG, Dilberis G, Barnaba A. Rapid and sensitive high-pressure liquid chromatographic method for monitoring carbamazepine levels in serum. Br J Clin Pharmacol. 1981; 11: 393-395. http://www.ncbi.nlm.nih.gov/pubmed/7259934
11. Mandrioli R, Fiorenzo A, Giovanna C, Cesare S, Augusta RM. Simultaneous high-performance liquid chromatography determination of carbamazepine and five of its metabolites in plasma of epileptic patients. J Chromatogr B. 2001; 762: 109-116. http://dx.doi.org/10.1016/S0378-4347(01)00328-0
12. Farthing D, Karnes T, Gehr TWB, March C, Fakhry I, Sica DA. External-standard high-performance liquid chromatographic method for quantitative determination of furosemide in plasma by using solid-phase extraction and on-line elution. J Pharm Sci. 1991; 81: 569-571. http://dx.doi.org/10.1002/jps.2600810621
13. Matsuura A, Nagayama T, Kitagawa T. Automated high-performance liquid chromatographic method for determination of furosemide in dog plasma. J Chromatogr. 1993; 617: 339-343. http://dx.doi.org/10.1016/0378-4347(93)80510-B
14. Nava-Ocampo AA, Velázquez-Armenta EY, Reyes-Pérez H, Ramirez-Lopez E, Ponce-Monter H. Simplified method to quantify furosemide in urine by high-performance liquid chromatography and ultraviolet detection. J Chromatogr B. 1999; 730: 49-54. http://dx.doi.org/10.1016/S0378-4347(99)00176-0
15. Valizadeh H, Zakeri-Milani P, Islambulchilar Z, Tajerzadeh H. A Simple and Rapid High-Performance Liquid Chromatography Method for Determining Furosemide, Hydrochlorothiazide, and Phenol Red: Applicability to Intestinal Permeability Studies. J AOAC Int. 2006; 89: 88-89. http://www.ncbi.nlm.nih.gov/pubmed/16512233
16. Kulpmann WR. A gas-chromatographic method for the determination of carbamazepine, phenobarbital, phenytoin and primidone in the same extract of serum. J Clin Chem Clin Biochem. 1980; 18: 227-232. http://www.ncbi.nlm.nih.gov/pubmed/6991632
17. Lensmeyer GL, Gidal BE, Wiebe DA. Optimized High-Performance Liquid Chromatographic Method for Determination of Lamotrigine in Serum With Concomitant Determination of Phenytoin, Carbamazepine, and Carbamazepine Epoxide. Ther Drug Monit. 1997; 19: 292-300. http://dx.doi.org/10.1097/00007691-199706000-00009
18. Sawchuk RJ, Cartier LL. Liquid-chromatographic method for simultaneous determination of phenytoin and 5-(4-hydroxyphenyl)-5-phenylhydantoin in plasma and urine. Clin Chem. 1980; 26: 835-839. http://www.ncbi.nlm.nih.gov/pubmed/7379305
19. Shimoyama R, Ohkubo T, Sugawara K, Ogasawara T, Ozaki T, Kagiya A, Saito Y. Monitoring of phenytoin in human breast milk, maternal plasma and cord blood plasma by solid-phase extraction and liquid chromatography. J Pharm Biomed Anal. 1998; 17: 863-869. http://dx.doi.org/10.1016/S0731-7085(97)00277-X
20. Koljonen M, Hakala KS, Ahtola-Satila T, Laitinen L, Kostiainen R, Kotiaho T, Kaukonen AM, Hirvonen J. Evaluation of cocktail approach to standardise Caco-2 permeability experiments. Eur J Pharm Biopharm. 2006; 64: 379-387. http://dx.doi.org/10.1016/j.ejpb.2006.06.006
21. International Conference on Harmonisation. ICH Q2B. Validation of Analytical Procedures: Methodology, Step 4. http://www.ich.org (accessed on August 26, 2011).
22. International Conference on Harmonisation. ICH Q2(A). Validation of Analytical Procedures, Step 4. http://www.ich.org (accessed on August 26, 2011).
23. Uchida M, Fukazawa T, Yamazaki Y, Hashimoto H, Miyamoto Y. A modified fast (4 day) 96-well plate Caco-2 permeability assay. J Pharm Toxicol Met. 2009; 59: 39-43. http://dx.doi.org/10.1016/j.vascn.2008.10.006
24. Thiel-Demby VE, Humphreys JE, St. John Williams LA, Ellens HM, Shah N, Ayrton AD, Polli JW. Biopharmaceutics Classification System: Validation and learnings of an in vitro permeability assay. Mol Pharm. 2009; 6: 11-18. http://dx.doi.org/10.1021/mp800122b
25. Zhu C, Jiang L, Chen TM, Hwang KK. A comparative study of artificial membrane permeability assay for high throughput profiling of drug absorption potential. Eur J Med Chem. 2002; 37: 399-407. http://dx.doi.org/10.1016/S0223-5234(02)01360-0