Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND GLICLAZIDE IN BULK DOSAGE FORM

Sakshi Khedekar*, Amit Kharje, Gitanjali Kudatadkar, Hitakshi Keluskar, Gambhir Khandare, Prof. Swati Patil

Abstract

The goal of the current work is to create a straightforward, quick, affordable and UV-visible spectrophotometric derivative approach for the simultaneous measurement of gliclazide and metformin hydrochloride in pharmaceutical dosage forms and bulk. By using a solvent solution made up of distilled water and sodium hydroxide (NaOH), the technique improves drug solubility while using fewer hazardous organic solvents that are frequently used in traditional analytical techniques. To find the maximum absorption wavelengths of both medications, standard stock solutions were made and scanned over the UV spectrum. The highest absorbance of gliclazide and metformin hydrochloride was observed at about 229 and 233 nm, respectively. The simultaneous equation method was used to quantitatively estimate the medicines and calibration curves were built within appropriate concentration ranges. For criteria including linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ), the developed analytical technique was validated in accordance with standard guidelines. The validation findings showed great accuracy, adequate precision and decent linearity. As a result, the suggested spectrophotometric technique can be successfully used for regular quality control analysis of gliclazide and metformin hydrochloride in pharmaceutical formulations.

Keywords: Metformin Hydrochloride, Gliclazide, UV-Visible Spectrophotometry, Simultaneous Estimation, ICH Guidelines, Quality Control.