Development of glibenclamide validation method using UV-Spectrophotometry for solubility test in mesoporous mannitol

https://doi.org/10.22146/farmaseutik.v19i3.90435

Nindya Kusumorini(1*), Adhyatmika Adhyatmika(2), Sheria Itqan Biruni(3), Sukmarini Anugrahanti(4)

(1) Faculty of Pharmacy, Universitas Gadjah Mada
(2) Department of Pharmaceutic, Faculty of Pharmacy Universitas Gadjah Mada
(3) Undergraduate student, Faculty of Pharmacy Universitas Gadjah Mada
(4) Undergraduate student, Faculty of Pharmacy Universitas Gadjah Mada
(*) Corresponding Author

Abstract


This study was aimed to develop a validation method for glibenclamide in mesoporous mannitol using UV spectrophotometric method. This method was chosen because it is simple, sensitive, accurate, precise, reproducible and economical. The wavelength of glibenclamide (λ max) was obtained at 229 nm using ethanol and water in a ratio of 1:1. The linearity of glibenclamide was selected at a concentration of 5 - 17.5 µg/mL. Correlation coefficient (r) = 0.9998; intraday RSD < 1%; interday RSD < 2%, recovery 100 - 105%, LOD = 0.32 µg/mL and LOQ = 1.08 µg/mL, and has high sensitivity because the presence of mesoporous mannitol in the solution does not interfere with the reading process of glibenclamide. So it can be concluded that this method has good reproducibility based on the results of linearity, precision, and accuracy of glibenclamide and in accordance with ICH requirements, so this method can be used for routine analysis of glibenclamide compounds in mesoporous mannitol.


Keywords


glibenclamide; validation; spectrophotometric; mannitol; mesoporous

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References

Aa, T., Ah, B., Cj, B., 2016. Pharmacolog1y and therapeutic implications of current drugs for type 2 diabetes mellitus. Nature Reviews. Endocrinology, 12(10). https://doi.org/10.1038/nrendo.2016.86

Ahmed, N., Abo-zeid, Y., Sakran, W., 2023. Strategies Adopted to Improve Bioavailability of Glibenclamide: Insights on Novel Delivery Systems. Journal of Advanced Pharmacy Research, 7(1), 35–49. https://doi.org/10.21608/aprh.2022.168998.1199

Al-Khattawi, A., Koner, J., Rue, P., Kirby, D., Perrie, Y., Rajabi-Siahboomi, A., Mohammed, A. R., 2015. A pragmatic approach for engineering porous mannitol and mechanistic evaluation of particle performance. European Journal of Pharmaceutics and Biopharmaceutics, 94, 1–10. https://doi.org/10.1016/j.ejpb.2015.04.011

Elbahwy, I. A., Ibrahim, H. M., Ismael, H. R., Kasem, A. A., 2017. Enhancing bioavailability and controlling the release of glibenclamide from optimized solid lipid nanoparticles. Journal of Drug Delivery Science and Technology, 38, 78–89. https://doi.org/10.1016/j.jddst.2017.02.001

Gustavo González, A., Ángeles Herrador, M., 2007. A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles. TrAC Trends in Analytical Chemistry, 26(3), 227–238. https://doi.org/10.1016/j.trac.2007.01.009

Horwitz, W., 2002. AOAC Guidelines for Single Laboratory.

ICH., 2005. Q2 (R1),"Validation of analytical procedures: Text and methodology" ICH Harmonised Tripartite Guideline. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. https://doi.org/10.1163/ej.9789004163300.i-1081.897

Liu, H., Shang, K., Liu, W., Leng, D., Li, R., Kong, Y., Zhang, T., 2014. Improved oral bioavailability of glyburide by a self-nanoemulsifying drug delivery system. Journal of Microencapsulation, 31(3), 277–283. https://doi.org/10.3109/02652048.2013.843598

Nash, R. A., Wachter, A. H., 2003. Pharmaceutical Process Validation: An International. Routledge & CRC Press. https://www.routledge.com/Pharmaceutical-Process-Validation-An-International/Nash-Wachter/p/book/9780824708382

Rambiritch, V., Maharaj, B., Naidoo, P., 2014. Glibenclamide in patients with poorly controlled type 2 diabetes: A 12-week, prospective, single-center, open-label, dose-escalation study. Clinical Pharmacology : Advances and Applications, 6. https://doi.org/10.2147/CPAA.S54809

Saffari, M., Ebrahimi, A., Langrish, T., 2015. Highly-porous mannitol particle production using a new templating approach. Food Research International, 67, 44–51. https://doi.org/10.1016/j.foodres.2014.10.030

Saffari, M., Ebrahimi, A., Langrish, T., 2016a. A novel formulation for solubility and content uniformity enhancement of poorly water-soluble drugs using highly-porous mannitol. European Journal of Pharmaceutical Sciences: Official Journal of the European Federation for Pharmaceutical Sciences, 83, 52–61. https://doi.org/10.1016/j.ejps.2015.12.016

Saffari, M., Ebrahimi, A., Langrish, T., 2016b. Nano-confinement of acetaminophen into porous mannitol through adsorption method. Microporous and Mesoporous Materials, 227, 95–103. https://doi.org/10.1016/j.micromeso.2016.02.047

Sola, D., Rossi, L., Schianca, G. P. C., Maffioli, P., Bigliocca, M., Mella, R., Corlianò, F., Fra, G. P., Bartoli, E., Derosa, G., 2015. State of the art paper Sulfonylureas and their use in clinical practice. Archives of Medical Science, 11(4), 840–848. https://doi.org/10.5114/aoms.2015.53304

Srivastava, D., Fatima, Z., Kaur, C. D., Mishra, A., Nashik, S. S., Rizvi, D. A., Prasad, R., 2022. Glibenclamide–malonic acid cocrystal with an enhanced solubility and bioavailability. Drug Development and Industrial Pharmacy. https://www.tandfonline.com/doi/abs/10.1080/03639045.2022.2122987



DOI: https://doi.org/10.22146/farmaseutik.v19i3.90435

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