Pharmaceutical equivalence study of amoxicillin/clavulanic acid salt tablets commercially available in UAE pharmaceutical market

Abstract

Pharmaceutical equivalence in terms of physicochemical parameters and antimicrobial susceptibility/resistance of ten commercial products of UAE containing amoxicillin and clavulanic acid salts were evaluated to determine their level of compliance to the official monograph requirements. A validated RP-HPLC method was used for quantification of active pharmaceutical ingredients according to United State Pharmacopeia 40-National Formulary-35. The system suitability study indicated the retention times and peak areas were reproducible and were suitable for the identification and quantification of amoxicillin/clavulanic acid salts within tablets of studied products. The physical parameters test results as hardness, friability, weight variations and disintegration times were also within ranges and complied with the official monographs. The rate of dissolution of amoxicillin and clavulanic acid salts from tablet dosage form in 30 min was within United State Pharmacopeia 40-National Formulary-35 limits. The dissolution profiles were compared with a reference product, using eight data points. The similarity factor (f2) and difference factor (f1) were calculated and the results indicated that all the products were 50-51% similar with the reference product. The f1 were also below 15% except a product's clavulanic acid content. The antimicrobial susceptibility/resistance study results showed that all the products were active against Escherichia coli, Staphylococcus aureus and Streptococcus pneumonia except Pseudomonas aeruginosa, which was resistant to amoxicillin/clavulanic acid salt. The minimum inhibitory concentration and minimum bacterial concentrations against these bacteria were also determined using broth dilution method. In conclusion, this study indicated all the studied products were pharmaceutically equivalent in respect of physicochemical parameters and antimicrobial activity.