PHARMASPIRE - Volume 12, Issue 1, January-March, 2020

Pages: 11-15

Date of Publication: 14-Jun-2022

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UV spectrophotometric method development and validation for the estimation of metformin hydrochloride in bulk and formulations

Author: Adity Sharma, S. S. Ganti

Category: Pharmaceutics

Abstract:

Aim and Objective: The aim of the study was to develop simple, reliable, accurate, cost-effective, and precise UV method for the determination of metformin hydrochloride in bulk and formulation. Materials and Methods: From API, 1 mg/mL solution was prepared and further diluted to prepare working standard solutions. Distilled water was selected as a solvent due to greater solubility and lambda max observed at 232 nm. The method was validated as per ICH guidelines. Results: Linearity range and correlation coefficient were 2–10 mcg/mL and 0.9995, respectively. The percentage recoveries of all the brands of metformin hydrochloride formulations were found within the limit of 99–101% with %RSD of <2% which showed our method is reliable. The method was precise as the %RSD is <2%. The detection limit and quantification limit were obtained for the proposed developed method 0.1270 µg/mL and 0.3848µg/ mL, respectively. Conclusion: From the above results, we conclude that this can be used for routine quantitative assessment of this drug in bulk and formulations can be implemented successfully.

Keywords: Metformin hydrochloride, UV spectrophotometric, antidiabetic, method validation

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