Quality of branded-generics versus branded products for Amoxicillin trihydrate and Potassium clavulanate tablets

Abstract

The research work aimed to explore the quality of branded versus branded-generic tablet dosage forms containing Amoxicillin trihydrate equivalent to Amoxicillin+Potassium Clavulanate equivalent to Clavulanic acid. The analytical methods such as identification test, uniformity of content and tests for dissolution were carried out during the course of the study. The average assay value for Amoxicillin and Clavulanic acid contents obtained after analysis of different batches of drug product using HPLC method were found within limits. Moreover, both the variants exhibited almost identical dissolution profiles using HPLC method. It was concluded that no difference in the quality of various branded and branded-generic samples of Amoxycillin trihydrate+Potassium Clavulanate tablets were noted that entailed the same quality of branded-generics tablet formulations as that of the leading branded products.