Authors : B. Rama; D. Sruthi; G. Keerthana; A. Akhila; Ashik Mandal; Ch. Vinay; Dr. Srinivas Chinta

Volume/Issue : Volume 10 - 2025, Issue 6 - June

Google Scholar : https://tinyurl.com/mjvcfvar

DOI : https://doi.org/10.38124/ijisrt/25jun709

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : Background: Glibenclamide, a second-generation sulfonylurea, is widely used to treat type 2 diabetes. The precise measurement of this medication is essential to ensuring the quality and therapeutic efficacy of drug products.  Objective: The current work is intended to develop and validate a simple and cost-effective UV-visible spectrophotometric approach for quantifying Glibenclamide in distilled water.  Methods: To improve solubility, Glibenclamide was dissolved in a tiny proportion of methanol before being diluted with distilled water to make a standard solution. Absorbance was measured at a maximum wavelength of 324 nm. According to the ICH Q2(R1) criteria, the technique was validated by finding the limit of detection (LOD) and limit of quantification (LOQ), which examined critical aspects such as linearity, accuracy, precision, specificity, robustness, and sensitivity.  Results: The novel approach showed a good linear response from 2-10 μg/mL, with a correlation value (R2) 0.9991. The accuracy was proven by recovery outcomes ranging from 98.47% to 101.21%. Precision was proved by keeping %RSD assessments below 2%. The detection and quantification limits were 0.35μg/mL and 1.06μg/mL. Furthermore, the approach demonstrated significant specificity and remained steady despite minor changes in analytical conditions, illustrating its robustness.  Conclusion: The validated UV-visible spectrophotometric technique for routine testing of Glibenclamide in distilled water proved trustworthy, consistent, and practical. It provides an efficient option for labs without access to sophisticated equipment like HPLC.

Keywords : Glibenclamide, UV-Visible Spectrophotometry, Method Validation, ICH Q2 (R1).

References :

1. ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation; 2005.
2. Indian Pharmacopoeia. Glibenclamide Monograph. Government of India, Ministry of Health and Family Welfare; Latest Edition.
3. Bilal M, Faisal N, Shah MA. Development and validation of analytical method for qualitative and quantitative Determination of Glibenclamide in different brands of tablets. Journal Chromatogr Sep Tech. 2022;13(1):543.
4. https://www.hilarispublisher.com/open-access/development-and-validation-of-analytical-method-for-qualitative-and-quantitative-determination-of-glibenclamide-in-diffe-34386.html
5. Bachri MS. Simultaneous assay of metformin HCl and Glibenclamide in tablet dosage form using area under curve and multiple wavelength spectrophotometric methods. Int J Appl Pharm. 2019;11(5):93–97.
6. https://doi.org/10.22159/ijap.2019v11i5.34022
7. Adegoke OA, Umoh OE. UV Spectrophotometric Determination of Glibenclamide in Dosage Forms Using p-Benzoquinone Reagent. Int J Pharm Pharm Sci. 2009;1(1):170–175.
8. Khan S, Patel MA, Desai AB. UV-visible spectrophotometric method development and validation for estimation of Glibenclamide in bulk. Int J Pharm Clin Anal. 2023;10(1):33–37.
9. https://www.ijpca.org/html-article/19181
10. British Pharmacopoeia. Glibenclamide Monograph. The Stationery Office; Latest Edition.
11. Apriani DS, Irfandhi Y, Dyaningtyas RS, Pratiwi A. Preliminary content of Glibenclamide and its metabolite 4-trans-hydroxyglibenclamide using UV-Vis spectrophotometry method. ResearchGate Preprint. 2024.
12. https://www.researchgate.net/publication/383471726
13. Kusumorini N, Ratri IMM, Riani M. Development and validation of UV spectrophotometric method of Glibenclamide in mesoporous mannitol. Majalah Farmaseutik. 2023;19(1):1–10.
14. https://doi.org/10.22146/mf.90435