A rapid and sensitive bioanalytical hplc method for determining diclofenac sodium in human plasma for bioequivalence studies

Journal of Liquid Chromatography and Related Technologies

Volumn 35, Issue 15, 2012, Pages 2203-2216

  Emara, Laila H ^a   Taha, Nesrin F ^a   El Ashmawy, Ahmed A ^a   Raslan, Hala M ^a   Mursi, Nadia M ^b  

^a NATIONAL RESEARCH CENTRE   (Egypt)

^b CAIRO UNIVERSITY   (Egypt)

Author keywords

bioanalytical; bioequivalence; HPLC UV VIS; pharmacokinetic; stability studies; voltaren

Indexed keywords

BIOANALYTICAL; BIOEQUIVALENCE; HPLC-UV; STABILITY STUDY; VOLTAREN;

ACETONITRILE; AUTOMOBILE MANUFACTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PRESSURE LIQUID CHROMATOGRAPHY; METHANOL; PHARMACOKINETICS; PLASMA (HUMAN); PLASMAS; SODIUM;

PLASMA STABILITY;

DICLOFENAC; METHANOL;

ACCURACY; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG MANUFACTURE; DRUG RELEASE; DRUG STABILITY; DRUG STORAGE; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; REPRODUCIBILITY; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 84866983013     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826076.2011.629391     Document Type: Article

References (38)

1. Menasse, R.; Hedwall, P. R.; Kraetz, J.; Pericin, C.; Riesterer, L.; Sallmann, A.; Ziel, R.; Jaques, R. Pharmacological Properties Of Diclofenac Sodium And Its Metabolites. Scand. J. Rheumatol. Suppl. 1978, 22, 5-16.
2. Ku, E. C.; Wasvary, J. M.; Cash, W. D. Diclofenac Sodium (GP 45840, Voltaren), A Potent Inhibitor Of Prostaglandin Synthetase. [In Vitro;]. Biochem. Pharmacol. 1975, 24 (5), 641-643.
3. Furst, D. E.; Munster, T. Nonsteroidal Anti-Inflammatory Drugs, Disease Modifying Antirheumatic Drugs, Nonopioid Analgesics and Drugs Used in Gout. In B. G. Katzung (Ed.), Basic And Clinical Pharmacology (8th ed., pp. 604, 598-599); Mc Graw-Hill: New York, 2001.
4. Reynolds, J. E. F. Martindale, The Extra Pharmacopoeia (33 ed.); The Royal Pharmaceutical Society, Great Britain: London, 2002.
5. Brogden, R. N.; Heel, R. C.; Pakes, G. E.; Speight, T. M.; Avery, G. S. Diclofenac Sodium: A Review of Its Pharmacological Properties and Therapeutic Use in Rheumatic Diseases and Pain of Varying Origin. Drug 1980, 20 (1), 24-48.
6. Fowler, P. D.; Shadforth, M. F.; Crook, P. R.; John, V. A. Plasma and Synovial Fluid Concentrations of Diclofenac Sodium and Its Major Hydroxylated Metabolites During Long-Term Treatment of Rheumatoid Arthritis. Eur. J. Clin. Pharmacol. 1983, 25 (3), 389-394.
7. Hasan, M. M.; Najib, N. M.; Rawashdeh, N. M.; Sallam, E. N.; Shubair, M. S.; Alawneh, Y. Comparative Bioavailability of Two Tablet Formulations of Diclofenac Sodium in Normal Subjects. Int. J. Clin. Pharmacol. Ther. Toxicol. 1991, 29 (5), 178-183.
8. Terhaag, B.; Gramatte, T.; Hrdlcka, P.; Richter, K.; Feller, K. The Influence of Food on the Absorption of Diclofenac as a Pure Substance. Int. J. Clin. Pharmacol. Ther. Toxicol. 1991, 29 (10), 418-421.
9. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. Center for Drug Evaluation and Research (CDER): Rockville, MD, USA, 2003. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf (accessed April 22, 2010).
10. El-Sayed, Y. M.; Abdel-Hameed, M. E.; Suleiman, M. S.; Najib, N. M. A Rapid and Sensitive High-Performance Liquid Chromatographic Method for the Determination of Diclofenac Sodium in Serum and Its Use in Pharmacokinetic Studies. J. Pharm. Pharmacol. 1988, 40 (10), 727-729.
11. Moncrieff, J. Extractionless Determination of Diclofenac Sodium in Serum Using Reversed-Phase High-Performance Liquid Chromatography with Fluorimetric Detection. J. Chromatogr. 1992, 577 (1), 185-189.
12. Avgerinos, A.; Karidas, T.; Malamataris, S. Extractionless High-Performance Liquid Chromatographic Method for the Determination of Diclofenac in Human Plasma and Urine. J. Chromatogr. 1993, 619 (2), 324-329.
13. Madni, A. U.; Ahmad, M.; Akhtar, N.; Usman, M. New Simultaneous High Performance Liquid Chromatographic Method for Determination of NSAIDs and Opioid Analgesics in Advanced Drug Delivery Systems and Human Plasma. World Acad. Sci. Eng. Technol. 2009, 55, 158-163.
14. Nouh, A. T.; Abd El-Gawad, A. H.; Guda, T. K. Stability, Bioavailability, and Ulcerative Activity of Diclofenac Sodium-Mastic Controlled Release Tablets. Drug Disc. Therap. 2010, 4 (2), 93-99.
15. Zecca, L.; Ferrario, P.; Costi, P. Determination of Diclofenac and Its Metabolites in Plasma and Cerebrospinal Fluid by High-Performance Liquid Chromatography with Electrochemical Detection. J. Chromatogr. Bio. App. 1991, 567 (2), 425-432.
16. Mason, J. L.; Hobbs, G. J. A Rapid High Performance Liquid Chromatographic Assay for the Measurement of Diclofenac in Human Plasma. J. liq. Chromatogr. 1995, 18, 2045-2058.
17. Hirai, T.; Matsumoto, S.; Kishi, I. Simultaneous Analysis of Several Non-Steroidal Anti-Inflammatory Drugs in Human Urine by High-Performance Liquid Chromatography with Normal Solid-Phase Extraction. J. Chromatogr. B 1997, 692 (2), 375-388.
18. Millership, J. S.; Hare, L. G.; Farry, M.; Collier, P. S.; McElnay, J. C.; Shields, M. D.; Carson, D. J. The Use of Hydrophilic Lipophilic Balanced (HLB) Copolymer SPE Cartridges for the Extraction of Diclofenac from Small Volume Paediatric Plasma Samples. J. Pharm. Biomed. Anal. 2001, 25 (5-6), 871-879.
19. Arcelloni, C.; Lanzi, R.; Pedercini, S.; Molteni, G.; Fermo, I.; Pontiroli, A. High-Performance Liquid Chromatographic Determination of Diclofenac in Human Plasma After Solid-Phase Extraction. J. Chromatogr. B 2001, 763 (1-2), 195-200.
20. Plavsic, F.; Culig, J. Determination of Serum Diclofenac by High-Performance Liquid Chromatography by Electromechanical Detection. Hum. Toxicol. 1985, 4 (3), 317-322.
21. Blagbrough, I. S.; Daykin, M. M.; Doherty, M.; Pattrick, M.; Shaw, P. N. High-Performance Liquid Chromatographic Determination of Naproxen, Ibuprofen and Diclofenac in Plasma and Synovial Fluid in Man. J. Chromatogr. B 1992, 578 (2), 251-257.
22. Torres-Lopez, J. E.; Robles, M. B.; Perez-Urizar, J.; Flores-Murrieta, F. J.; Granados-Soto, V. Determination of Diclofenac in Micro-Whole Blood Samples by High-Performance Liquid Chromatography with Electrochemical Detection. Application in a Pharmacokinetic Study. Arzneimittelforschung 1997, 47 (9), 1040-1043.
23. Giagoudakis, G.; Markantonis, S. L. An Alternative High-Performance Liquid-Chromatographic Method for the Determination of Diclofenac and Flurbiprofen in Plasma. J. Pharm. Biomed. Anal. 1998, 17 (4-5), 897-901.
24. Roskar, R.; Kmetec, V. Liquid Chromatographic Determination of Diclofenac in Human Synovial Fluid. J. Chromatogr B 2003, 788 (1), 57-64.
25. Emami, J.; Ghassami, N.; Talari, R. A Rapid and Sensitive Modified HPLC Method for Determination of Diclofenac in Human Plasma and Its Application in Pharmacokinetic Studies. DARU 2007, 15 (3), 132-138.
26. Ashok, T.; Naidu, K. V.; Rajesh, V.; Mohan, E. C.; Rao, Y. M. Development of Biopolymer Based Matrix Type Multiple Unit Systems for Sustained Release of Diclofenac Sodium: In Vitro and In Vivo Evaluation. J. Macro. Sci. A 2008, 45 (3), 255-260.
27. Lee, H. S.; Kim, E. J.; Zee, O. P.; Lee, Y. J. High Performance Liquid Chromatographic Determination of Diclofenac Sodium in Plasma Using Column-Switching Technique for Sample Clean-Up. Arch. Pharm. (Weinheim) 1989, 322 (11), 801-806.
28. Lee, H. S.; Jeong, C. K.; Choi, S. J.; Kim, S. B.; Lee, M. H.; Ko, G. I.; Sohn, D. H. Simultaneous Determination of Aceclofenac and Diclofenac in Human Plasma by Narrowbore HPLC Using Column-Switching. J. Pharm. Biomed. Anal. 2000, 23 (5), 775-781.
29. Su, S. F.; Chou, C. H.; Kung C. F.; Huang, J. D. In Vitro and In Vivo Comparison of Two Diclofenac Sodium Sustained Release Oral Formulations. Int. J. Pharm. 2003, 260 (1), 39-46.
30. Magosso, E.; Yuen, K. H.; Choy, W. P.; Ling, S. S.; Ng, B. H.; Ur-Rahman, N.; Wong, J. W. Comparative Bioavailability Study of a Generic Sustained Release Diclofenac Sodium Tablet. Med. J. Malaysia (August) 2004, 59 (3), 352-356.
31. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, FDA (2001) Center of Drug Evaluation and Research (CDER), Rockville, MD, USA,
32. Emara, L. H.; Taha, N. F.; Mursi, N. M. Investigation of the Effect of Different Flow-Through Cell Designs on the Release of Diclofenac Sodium SR Tablets. Dissolution Technol. 2009, May, 23-31.
33. Gibaldi, M.; Perrier, D. Pharmacokinetics, 2nd, ed.; New York: Marcel Dekker, 1982.
34. Said, S. A.; Sharaf, A. A. Pharmacokinetics of Diclofenac Sodium Using a Developed HPLC Method. Arzneimittelforschung 1981, 31 (12), 2089-2092.
35. Raz, I.; Bialer, M.; Salame, K.; Bar-On, H. Comparative Pharmacokinetic Analysis of a Novel Sustained-Release Dosage Form of Theophylline in Humans. Eur. J. Clin. Pharmacol. 1984, 26 (3), 401-403.
36. Hasan, M. M.; Najib, N. M.; Muti, H. A Comparative Bioavailability Study on Two Sustained-Release Formulations of Diclofenac Sodium Following a Single Dose Administration. Int. J. Clin. Pharmacol. Ther. Toxicol. 1993, 31 (8), 387-391.
37. Rani, M.; Surana, R.; Sankar, C.; Mishra, B. Development and Biopharmaceutical Evaluation of Osmotic Pump Tablets for Controlled Delivery of Diclofenac Sodium. Acta Pharm. 2003, 53 (4), 263-273.
38. Taha, N. F. Development and Evaluation of Diclofenac Sodium in Controlled Release Oral Drug Delivery Systems. Ph.D. Thesis, 2011. Faculty of Pharmacy, Cairo University, Egypt.