Abstract

TO COMPARE EVALUATION PARAMETERS OF BRANDED AND GENERIC PREPARATION OF METRONIDAZOLE TABLET

Nikhil Inamke*, Nikita Jadhav, Ms. Komal Baride

ABSTRACT

The present study was undertaken to compare the pharmaceutical quality control parameters of branded and generic preparations of Metronidazole 400 mg tablets. Both formulations were evaluated for general appearance, solubility, melting point, UV-Visible spectroscopic analysis (calibration curve, λmax, drug content), weight variation, hardness, friability, disintegration, moisture content, and dissolution profile. The λmax of Metronidazole was found to be 319.7 nm with R² = 0.9805 confirming linearity (Beer–Lambert’s law). Drug content for branded tablets ranged from 97.94% to 99.05% and for generic tablets from 98.97% to 99.72%, both within acceptable IP limits. Weight variation, hardness, friability, disintegration, and moisture content results were within pharmacopeial limits for both formulations. Dissolution studies revealed that branded tablets achieved approximately96–99% drug release at 60 minutes, while generic tablets showed 95–99% drug release at the same time point. The results indicate that both branded and generic Metronidazole tablet formulations comply with official pharmacopeial standards and are pharmaceutically equivalent, suggesting that the generic preparation can serve as a cost-effective alternative to the branded product.

Keywords: Metronidazole, Generic medicine, Branded medicine, Tablet evaluation, Dissolution study, Pharmaceutical equivalence.