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Potency of Posaconazole Tablet Formulations Manufactured and Marketed in Bangladesh
Subject area: Biological & Medical Sciences · Area of research: Biopharmaceutical analysis
Abstract
Background: Posaconazole is a widely used antifungal drug known for its potency against various fungal infections. The determination of its potency is crucial for ensuring the appropriate dosage and efficacy of the drug samples. UV spectroscopy is a widely accepted method for the quantitative analysis of pharmaceutical active ingredients of drug samples. There is no study available on determination of potency of posaconazole, marketed in Bangladesh, by UV spectroscopy. Aims & Objectives: The present research work aims to determine the potency of posaconazole drug products of various pharmaceutical companies of Bangladesh using UV spectroscopic method and to discuss the findings. Significant findings: The UV method involves measuring the absorbance of posaconazole. In this study lambda max (?max) was found at 264 nm for posaconazole in methanol . From the absorbance of the standard solutions at different concentrations, the regression equation was found as y = 0.0487x + 0.0088 and the coefficient of determination (R2) was evaluated as 0.9997, which indicated topnotch linearity of the calibration curve and data fitting. The absorbance of samples of four (4) different tablets solutions were measured and the concentrations were calculated using the regression equation. Concentrations were found 19.1752 ?g/mL, 18.8542 ?g/mL, 19.2806 ?g/mL, 19.3094 ?g/mL and potency of the samples were evaluated 95.87%, 94.27%, 96.40%, 96.55%, respectively. It was found that all of the drug samples complied with the acceptance level stated in US Pharmacopeia. The decreasing order of potencies of the samples is Sample-4 (of ACI)> Sample-3 (of Opsonin)> Sample-1 (of Square)> Sample-2 (of Square).
References
[1] Andes, D.R., Dismukes,W.E., Azoles,in: Kauffman,C.A., Pappas, P.G., Sobel, J.D. (2011). Dismukes WE (Eds.). Essentials Clin. Mycol., 2nd ed., Springer-Verlag New York, New York, 61–93. doi:10.1007/978-1-4419-6640-7.
[2] Andressa,S.B., Sendy,S.O., Andreas,S.L.M., Cassia,V.G.(2015).UV Spectrophotometric method for determination of posaconazole: Comparison to HPLC. Revista de Ciências Farmacêutica Básica e Aplicadas - RCFBA, 36(4):491-495
[3] Chen, L., Krekels, E.H.J., Verweij, P.E., Buil, J.B., Knibbe, C.A.J., Brüggemann. R.J.M.(2020). Pharmacokinetics and Pharmacodynamics of Posaconazole, Drugs, 80:671–695 https://doi.org/10.1007/s40265-020-01306-y
[4] Deepali, G., & Elvis, M. (2010).UV Spectrophotometric Method for Assay of the Anti-Retroviral Agent Lamivudine in Active Pharmaceutical Ingredient and in its Tablet Formulation. J Young Pharm.,2(4): 417–419.
[5] European Medicines Agency, 2010. Summary of posaconazole characteristics. https://www.ema.europa.eu/en/documents/product-information/noxafil-epar-product- information_en.pdf. Accessed on 15 Apr 2020
[6] Farowski, F., Vehreschild, J.J., Cornely, O.A .(2007). Posaconazole: A next-generation triazole antifungal. Future Microbiol., 2: 231–243. doi:10.2217/17460913.2.3.231
[7] Kauffman,C.A., Malani, A.N., Easley,C., Kirkpatrick, P (2007). Posaconazole, Nat. Rev. Drug Discov., 6:183–184. doi:10.1038/nrd2270.
[8] Krieter, P., Flannery, B., Musick, T., Gohdes, M., Martinho, M., Courtney, R.(2004).Disposition of Posaconazole following Single-Dose Oral Administration in Healthy Subjects. ASM Journals., 48(9): 3543-3551.
[9] Kujawski, J., Czaja, K., Dettlaff, K., Żwawiak, J., Ratajczak,T., Bernard, M.K.(2019). Structural and spectroscopic properties of posaconazole – Experimental and theoretical studies, Journal of Molecular Structure., 1181: 179-189. doi: https://doi.org/10.1016/j.molstruc.2018.12.074.
[10] Moore,J.N., Healy, J.R., Kraft, W.K. (2015). HHS Public Access, Expert Rev. Clin. Pharmacol.,8: 321–334. doi:10.7205/MILMED-D-14-00168. Long-chain.
[11] Peyton, L.R., Gallagher, S., Hashemzadeh, M. (2015). Triazole antifungals: A review. Drugs of Today., 51(12): 705–718. doi:10.1358/dot.2015.51.12.2421058.
[12] Rhoden, E., Nix,W.A., Weldon,W.C., Selvarangan, R.(2018). Antifungal azoles itraconazole and posaconazole exhibit potent in vitro antiviral activity against clinical isolates of parechovirus A3 (Picornaviridae), Antiviral Res.,149: 75–77. doi:10.1016/j.antiviral.2017.11.011.
[13] Suleman, S., Verheust, Y., Dumoulin, A., Wynendaele, E. D'., Hondt, M., Vandercruyssen, K., Veryse, L., Duchateau, L., Spiegeleer, B.D. (2015). Gas chromatographic method for the determination of lumefantrine in antimalarial finished pharmaceutical products Journal of Food and Drug Analysis. 2015; 23(3): 552-559.
[14] USFDA, 2015. Noxafil instruction. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205053s1lbl.pdf. Accessed on 15 Apr 2020.
[15] USP, 2007.United States Pharmacopeia and National Formulary (USP 30-NF 25). Rockville, MD: United States Pharmacopeial Convention; 2007.
[16] Yilmaz, B., Bayrak, B., and Kadioglu, Y.(2022). Development and Validation of HPLC Method for the Determination of Flurbiprofen in Pharmaceutical Preparations. International Journal of Pharm ATA , 2(3): 72-81.
How to cite this paper
@article{1705744,
author = {Shrabony Mazumder, Rupa Akter, Md. Rafiquzzaman},
title = {Potency of Posaconazole Tablet Formulations Manufactured and Marketed in Bangladesh},
journal = {Iconic Research And Engineering Journals},
year = {2024},
volume = {7},
number = {11},
pages = {7-12},
issn = {2456-8880},
url = {https://www.irejournals.com/formatedpaper/17057441.pdf},
abstract = {Background: Posaconazole is a widely used antifungal drug known for its potency against various fungal infections. The determination of its potency is crucial for ensuring the appropriate dosage and efficacy of the drug samples. UV spectroscopy is a widely accepted method for the quantitative analysis of pharmaceutical active ingredients of drug samples. There is no study available on determination of potency of posaconazole, marketed in Bangladesh, by UV spectroscopy.
Aims & Objectives: The present research work aims to determine the potency of posaconazole drug products of various pharmaceutical companies of Bangladesh using UV spectroscopic method and to discuss the findings.
Significant findings: The UV method involves measuring the absorbance of posaconazole. In this study lambda max (?max) was found at 264 nm for posaconazole in methanol . From the absorbance of the standard solutions at different concentrations, the regression equation was found as y = 0.0487x + 0.0088 and the coefficient of determination (R2) was evaluated as 0.9997, which indicated topnotch linearity of the calibration curve and data fitting.
The absorbance of samples of four (4) different tablets solutions were measured and the concentrations were calculated using the regression equation. Concentrations were found 19.1752 ?g/mL, 18.8542 ?g/mL, 19.2806 ?g/mL, 19.3094 ?g/mL and potency of the samples were evaluated 95.87%, 94.27%, 96.40%, 96.55%, respectively. It was found that all of the drug samples complied with the acceptance level stated in US Pharmacopeia. The decreasing order of potencies of the samples is Sample-4 (of ACI)> Sample-3 (of Opsonin)> Sample-1 (of Square)> Sample-2 (of Square).},
month = {May},
}