An Innovative UV-Visible Spectrophotometric Approach for the Quantitative Assessment of Glibenclamide in API and Dosage Form

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.