Development and validation of new HPLC-methods for estimation of fluconazole in different simulated biological fluids: A comparative study

Journal of Liquid Chromatography and Related Technologies

Volumn 37, Issue 4, 2014, Pages 594-607

  Singh, Amit ^a   Sharma, Pramod K ^b   Majumdar, Dipak K ^c  

^a RV Northland Institute   (India)

^b MEERUT INSTITUTE OF ENGINEERING AND TECHNOLOGY   (India)

^c DELHI INSTITUTE OF PHARMACEUTICAL SCIENCES AND RESEARCH   (India)

Author keywords

Assays; Fluconazole; Gastric fluid simulant; Reverse phase high performance liquid chromatography; Vaginal fluid stimulant; Validation

Indexed keywords

ASSAYS; COLUMN CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHANOL;

BIOLOGICAL FLUIDS; CALIBRATION CURVES; COMPARATIVE STUDIES; FLUCONAZOLE; GASTRIC FLUIDS; UNITED STATES FOOD AND DRUG ADMINISTRATIONS; VAGINAL FLUID STIMULANT; VALIDATION;

BODY FLUIDS;

ACETONITRILE; FLUCONAZOLE; PHOSPHATE BUFFERED SALINE; PHOSPHORIC ACID;

ARTICLE; BODY FLUID; CALIBRATION; COMPARATIVE STUDY; FLOW RATE; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PH; QUALITY CONTROL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; STOMACH JUICE; VAGINA DISCHARGE; VALIDATION STUDY;

EID: 84896517126     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826076.2012.758131     Document Type: Article

References (43)

1. Grant, S. M.; Clissold, S. P. Fluconazole a Review of its Pharmacodynamic and Pharmacokinetic and Therapeutic Potential in Superficial and Systemic Mycoses. Drugs. 1990, 39, 877-916.
2. Meshram, D. B.; Bagade, S. B. T. Simple HPLC Method for Simultaneous Estimation of Fluconazole and Tinidazole in Combined Dose Tablet. M. R. J. Chromatogr. Sci. 2009, 47, 885-888.
3. Banks, C. T. Development and Application of Coupled HPLC-TLC for Pharmaceutical Analysis. J. Pharm. Biomed. Anal. 1993, 11, 705.
4. Roychowdhury, U.; Das, S. K. Rapid Identification and Quantitation of Clotrimazole, Miconazole and Ketoconazole in Pharmaceutical Creams and Ointment by Thin-Layer Chromatography- Densitometry. J. Assoc. off Anal. Chem. 1996, 79, 656.
5. Mushik, O. V.; Tkach, V. I.; Karandeeva, N. I.; Glukhova, O. I.; Tsyganok, L. P. Electrochemical and Analytical Properties of Solid Contact Ionselective Electrode Reversible to the Imidazole Derivatives, Clotrimazole and Bifonazole. J. Anal. Chem. 1998, 53, 1110.
6. Fijelek, Z.; Chodkowski, J.; Wawowna, M. Polarographic Determination of Derivatives of Imidazole, Clotrimazole and Ketokonazole. Acta Pol. Pharm. 1992, 49, 1.
7. Zhao, C.; Zhu, L.; Zhang, F.; Wang, X. Quantitative Determination of Clotrimazole pH Indicator Absorbance Ratio Method. Analytical. Abstr. 1993, 55 (7G), 135.
8. Massaccesi, M. Two Phase Titration of Some Imidazole Derivative in Pharmaceutical Preparations. Analyst. 1986, 111, 987.
9. Dean, J. R.; Fowlis, I. A.; Hitchen, S. M.; Khunker, S.; Ludkin, E.; Normand, F. J. Determination of Antifungal in Rodent Diet by Supercritical Fluid Extraction Followed by Packed Column Supercritical Fluid Chromatography with Ultraviolet Detection. J. Assoc. of Anal. Chem. 1997, 80, 7.
10. Ritter, J. M.; Lewis, L.; Mant, T. G. K. A Textbook of Clinical Pharmacology, 4th Ed.; Arnold: London, 1999; Vol. 14, pp 423-424.
11. Aboul-Enein, H. Y.; Goger, N. G.; Turkalp, A. Quantitative Determination of Fluconazole in Syrups by First Order Derivatives Spectrophotometery. Anal Lett. 2002, 35, 1193-1204. (Pubitemid 34804041)
12. Kocks, C. H. W.; Meenhorst, P. L. Pharmacokinetics of Fluconazole in Saline and Plasma After Administration of an Oral Suspension and Capsules. Antimicrob. Agents Chemother. 1996, 40 (80), 1935-1937. (Pubitemid 26277820)
13. Lu, F.; Fang, H.; Wu, Y. Investigation of Drug Compatibility by Convolution Spectrometry. Zhongguo Yiyvan Yaoxue Zazhi 1996, 16 (11), 505-506.
14. He, D.; Dongzhou, X. Determination of Fluconazole Content in Flz Injection by UV-Spectrometry. Guangdong Yaoxueyuan Xuebao. 1997, 13 (2), 107-108.
15. Goger, N. G.; Aboul-Enein, H. Y. Quantitative Determination of Flz Capsules and iv Solutions by UVSpectrophotometric Methods. Anal. Lett. 2001, 34 (12), 2089-2098. (Pubitemid 32963742)
16. Goger, N. G.; Aboul-Enein, H. Y. Quantitative Determination of Flz in Syrups by First Order Derivative Spectrophotometry. Turkalp Anal. Lett. 2001, 35 (7), 1193-1204.
17. Anand, R. M.; Kumar, T. R.; Nandakumar, N.; Saravanan, D.; Lalitha, K. G. Spectrophotometric Method for Estimation of Flz in Capsules. Indian Drugs. 2006, 43 (4), 320-322.
18. Kelani, K.; Bebawy, L. I. Spectrophotometric Determination of Some N-Donating Drugs Using DDQ. Anal. Lett. 1997, 30, 1843.
19. Sane, R. T.; Fulay, A.; Joshi, A. A. Quantification of Fluconazole From its Pharmaceutical Preparation by Simple Microbiological Method. Indian Drugs. 1994, 31 (5), 207-210. (Pubitemid 24257546)
20. Santos, D. A.; Queiroz, K. M.; Cesar, I. C. Comparison of Microbiological Assay and HPLC-UV for Determination of Fluconazole in Capsules. Braz. J. Pharm. Sci. 2009, 45, 693-700.
21. Hurtado, F. K.; Souza, M. J.; Melo, J. D.; Rolim, C. M.; Mian, B. Biological Assay and Hplc Methods for the Determination of Fluconazole in Pharmaceutical Injectable Formulation. Latain. Ameri. J. Pharm. 2008, 27 (2), 224-228. (Pubitemid 352019003)
22. Marchetti, O.; Majcherczyk, P. A.; Glauser, M. P.; Bille, J.; Moreillon, P.; Sanglard, D. Sensitive Bioassay for Determination of Fluconazole Concentration Plasma Using a Candida Albicans mutant Hyper Susceptible of Azoles. Antimicro. Agents Chemo. 2001, 45 (3), 696-700. (Pubitemid 32182010)
23. Mendes, F. E. S.; Oliveira, L. V. N.; Alvarenga, D. G.; Pinto, M. R.; Taborda, C. P.; Soares, B. M.; Cisalpino, P. S.; Santos, D. A. Correlation of the In-Vitro Antifungal Drug Susceptibility with the In-Vitro Activity of Fuconazole in a Murine Model of a Cerebral Infection Caused by Cryptococcus Gatti. Eur. J. Clin. Micro Infect. Dis. 2010, 29, 1525-1532.
24. Beijnen, J. H.; Meenhorst, P. L., Van-Gijn, R.; Hazclager, W. A.; Koks, C. H. W.; Underberg, W. J. M. Gas-Liquid Chromatographic Analysis, with Electron Captur Detection, of the Antifungal Drug Fluconazole in Microvolumes of Human Plasma. J. Pharma. Biomed Anal. 1991, 9, 1173.
25. Harris, S. C.; Wallace, F. G.; Rinaldi, M. G. Assay of Fluconazole by Megabore Capillary Gas Liquid Chromatography with Nitrogen-Selective Detection. Antimicrob. Agents Chemother. 1989, 33, 714.
26. Cociglio, M.; Brandissou, S.; Alric, R. High Performance Liquid-Chromatographic Determination of Fluconazole in Plasma. J. Chromatogr. B. 1996, 686, 11-17. (Pubitemid 26382453)
27. Rex, J.; Handson, L. H.; Amantea, M. A.; Stevens, D. A.; Bennett, J. E. Standardization of a Fluconazole Bioassay and Correlation of Results with Those Obtained by High-Pressure Liquid Chromatography. Antimicrob. Agents Chemother. 1991, 35, 846-850.
28. Sung-Su, K.; Ho-Taek, I.; Kang, I. I.; Heon-Woo, L. An Optimized Analytical Method of Fluconazole in Human Plasma by High-Performance Liquid Chromatography with Ultraviolet Detection and its Application to a Bioequivalence Study. J. Chromatogr-B 2007, 852, 174-179.
29. Aloudah, N. M.; Radwan, M. A. HPLC Assay of Fluconazole and its Application to Patients With Early Septic Shock. J. Liq. Chromatogr. Rel. Tech. 2005, 28, 571-580. (Pubitemid 40250695)
30. Majcherczyk, P. A.; Moreillon, P.; Decosterd, L. A.; Dominique, S.; Bille, J. Single Step Extraction of Fluconazole from Plasma by Ultra-Filtration for the Measurement of its Free Concentration by High Performance Liquid Chromatography. J. Pharm. Biomed. Anal. 2002, 128, 645-651. (Pubitemid 34465631)
31. Cociglio, M.; Brandissou, S.; Alric, R.; Bressolle, F. High Performance Liquid Chromatographic Determination of Fluconazole in Plasma. J. Chromatogr-B 1996, 686.
32. Koks, C. H. W.; Rosing, H.; Meenhorst, P. L.; Bult, A.; Beijnen, J. H. High Performance Liquid Chromatographic Determination of the Antifungal Drug Fluconazole in Plasma and Saliva of Human Immunodeficiency Virus-Infected Patients. J. Chromatogr-B 1995, 663, 345-351.
33. Sadasivudu, P.; Shastri, N.; Sadanandam, M. Developement and Validation of RP-HPLC and UV Methods of Analysis for Fluconazole in Pharmaceutical Solid Dosage Form. Int. J. Chem. Tech Res. 2009, 1 (4), 1131-1136.
34. Limpiti, D.; Lhieochaiphant, D.; O-ariyakul, N. High Performance Liquid Chromatographic Method for the Analysis of Fluconazole in Pharmaceutical Preparation. CMU J. 2006, 5 (3), 341.
35. Tendolkar, N. M.; Desai, B. S.; Shinde, V. M. Simultaneous Determination of Tinidazole, Clotrimazole from Tablets by Reversed Phase HPLC. Indian Drugs 1994, 31, 551.
36. Yuen, K. H.; Peh, K. K. Simple High-Performance Liquid Chromatographic Method for Determination of Ketoconazole in Human Plasma. Biomed. Appl. 1998, 715, 436.
37. Guo, Y.; Wen, J. W.; Yaowu, F. Z. High Performance Determination of the Content of Fluconazole in Eye-Drops. Yaowu Fenxi Zazhi. 1999, 19, 347.
38. Ayub, A. C.; Vianna-Soares, C. D.; Ferreira, L. Fluconazole Method Validation by RP-HPLC for Determination in Biological Skin Matrices. J. Chroma. Sci. 2007, 45, 286-290. (Pubitemid 46790137)
39. Vertzoni, M.; Dressman, J.; Butler, J.; Hepenstall, J.; Peppas, C. Simulation of Fasting Gastric Conditions and its Importance for the In-Vivo Dissolution of LipopHILIC Compounds. Eur. J. Pharm. Biopharm. 2005, 60, 413-417. (Pubitemid 40922839)
40. Owen, D. H.; Katz, D. F. A Vaginal Fluid Stimulant. Contraception. 1999, 59 (2), 91-95.
41. Indian Pharmacopoeia. Controller of Publications, Delhi, India. 1996, Vol-II, A-147.
42. Text on Validation of Analytical Procedures: Methodology (ICH Topic Q 2 B). International Conference on Harmonization (ICH) of the European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit, London, UK, 4(6) Nov., 1996.
43. FDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001. http://www.fda.gov/cder/guidance/index.htm (Accessed 2011)