VALIDATION OF A BIOANALYTICAL REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTITATION OF NYSTATIN IN AN ANIMAL MODEL AFTER INTRANASAL IN SITU GEL ADMINISTRATION
Objective: The aim of the study was to develop and validate a bioanalytical reverse-phase high-performance liquid chromatographic (HPLC) method for the estimation of nystatin in rat plasma after intranasal administration.
Methods: The reversed-phase HPLC system was equipped with a Luna C18 column, the mobile system comprised of methanol, water, and dimethylformamide (55:30:15) and the flow rate was set at 0.9 ml/min.
Results: The elution time for nystatin was 4.096±0.025 min. The calibration curves constructed in rat plasma were linear from 0.25 to 50 μg/ml. The lower limit of quantification (LOQ) was found to be 0.25 μg/ml. The standards for accuracy and precision of the intra- and inter-day variation studies were in the acceptable ranges as per the FDA guidelines.
Conclusion: The LOQ value determined by the proposed method was noted to be satisfactory for inspecting the plasma pharmacokinetics of nystatin in rats’ post-administration of a nasal in situ gelling liquid crystalline precursor formulation in an in vivo study.
2. Hamilton-Miller JM. Chemistry and biology of the polyene macrolide antibiotics. Bacteriol Rev 1973;37:166-96.
3. Wasan KM, Ramaswamy M, Cassidy SM, Kazemi M, Strobel FW, Thies RL. Physical characteristics and lipoprotein distribution of liposomal nystatin in human plasma. Antimicrob Agents Chemother 1997;41:1871-5.
4. Groll AH, Gonzalez CE, Giri N, Kligys K, Love W, Peter J, et al. Liposomal nystatin against experimental pulmonary aspergillosis in persistently neutropenic rabbits: Efficacy, safety and non-compartmental pharmacokinetics. J Antimicrob Chemother 1999;43:95-103.
5. Offner F, Krcmery V, Boogaerts M, Doyen C, Engelhard D, Ribaud P, et al. Liposomal nystatin in patients with invasive aspergillosis refractory to or intolerant of amphotericin B. Antimicrob Agents Chemother 2004;48:4808-12.
6. Groll AH, Petraitis V, Petraitiene R, Field-Ridley A, Calendario M, Bacher J, et al. Safety and efficacy of multilamellar liposomal nystatin against disseminated candidiasis in persistently neutropenic rabbits. Antimicrob Agents Chemother 1999;43:2463-7.
7. Rank MA, Adolphson CR, Kita H. Antifungal therapy for chronic rhinosinusitis: The controversy persists. Curr Opin Allergy Clin Immunol 2009;9:67-72.
8. Deutsch PG, Whittaker J, Prasad S. Invasive and non-invasive fungal rhinosinusitis-a review and update of the evidence. Med Kaunas Lith 2019;55:319-32.
9. Erd? F, Bors LA, Farkas D, Bajza Á, Gizurarson S. Evaluation of intranasal delivery route of drug administration for brain targeting. Brain Res Bull 2018;143:155-70.
10. Ghadiri M, Young PM, Traini D. Strategies to enhance drug absorption via nasal and pulmonary routes. Pharmaceutics 2019;11:113-32.
11. Sauer B, Matusch R. High-performance liquid chromatographic separations of nystatin and their influence on the antifungal activity. J Chromatogr A 1994;672:247-53.
12. Wilson P, Stewart A, Flournoy V, Zito SW, Vancura A. Liquid chromatographic determination of nystatin in pharmaceutical preparations. J AOAC Int 2001;84:1050-5.
13. Shokraneh F, Asgharian R, Abdollahpour A, Ramin M, Montaseri A, Mahboubi A. A novel high performance liquid chromatographic method for determination of nystatin in pharmaceutical formulations by Box- Behnken statistical experiment design. Iran J Pharm Res 2015;14:43-9.
14. Cione A, Liberale M, Silva P. Development and validation of an HPLC method for stability evaluation of nystatin. Braz J Pharm Sci 2010;46:305-10.
15. ICH Harmonized Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2 (R1). Parent Guidelines; 1994. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology.
16. FDA Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2001. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry.
17. Aruna G, Bharathi K, Koganti P. Development and validation of bioanalytical hplc method for simultaneous estimation of cilnidipine and nebivolol in human plasma. Int J Pharm Pharm Sci 2017;10:253-9.
18. Togami K, Fukuda K, Yamaguchi K, Chono S, Tada H. Facile and sensitive HPLC-UV method for determination of nintedanib in rat plasma. Int J Pharm Pharm Sci 2018;6:133-7.
19. Nagavi JB, Gurupadayya B. Simultaneous estimation of clopidogrel and atorvastatin in human plasma using bio-analytical RP-ultra fast liquid chromatographic method. Int J Curr Pharm Sci 2020;7:30-5.
20. Carvalho FC, Campos ML, Peccinini RG, Gremiao MP. Nasal administration of liquid crystal precursor mucoadhesive vehicle as an alternative antiretroviral therapy. Eur J Pharm Biopharm 2013;84:219-27.
21. Michel GW. Nystatin. In: Florey K, editor. Analytical Profiles of Drug Substances. Vol. 6. United States: Academic Press; 1977. p. 341-421. Available from: http://www.sciencedirect.com/science/article/pii/ S0099542808603494.
22. Llabot JM, Allemandi DA, Manzo RH, Longhi MR. HPLC method for the determination of nystatin in saliva for application in clinical studies. J Pharm Biomed Anal 2007;45:526-30.
23. Groll AH, Mickiene D, Werner K, Piscitelli SC, Walsh TJ. High-performance liquid chromatographic determination of liposomal nystatin in plasma and tissues for pharmacokinetic and tissue distribution studies. J Chromatogr B Biomed Sci Appl 1999;735:51-62.
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