Abstract

QUALITY EVALUATION OF VARIOUS BRANDS OF CEFUROXIME AXETIL TABLETS MARKETED IN UYO METROPOLIS USING DERIVATIVE PRODUCT

Arnold C. Igboasoiyi* and Aniefiok J. Okpoho

ABSTRACT

Cefuroxime Axetil (1-acetoxyethyl ester of cefuroxime) is a second generation semi-synthetic cephalosporin antibiotic used for the treatment of bone infections, otitis, sinusitis, skin and urinary tract infections. Ten brands of Cefuroxime Axetil sourced from various pharmacies in Uyo, Akwa Ibom State, Nigeria and coded A-J, were assayed for their physical characteristics such as friability, crushing strength, weight uniformity, and dissolution as well as disintegration rate using standard methods. The same brands were subjected to quantitative assay using spectrophotometry which was based on the formation of diazo complex of Cefuroxime Axetil with 1-nitroso-2-napthol in the presence of sodium hydroxide to give yellow-orange coloured chromogen with λmax peak at 280 nm. All the brands met with the specifications of United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) for weight variation except brands G and C which did not comply with the acceptable range of ± 5 for the percentage weight variation. All the brands had good compression characteristics as they all fell within the limits for crushing strength (4-10Kg/cm2). Eight (8) brands passed the friability test while two (2) brands (A, 1.18% and J, 1.32%) having weight losses of more than 1% (w/w) failed the test. All the different brands passed the disintegration test having disintegrated in less than 15 minutes as prescribed by the official compendium. None of the brands passed the dissolution rate test. Further comparison of the dissolution profiles using the f1 and f2 values of the various brands which were derived in comparison with the innovator-product, brand J, showed that brands A, B, E, G, H and I could be used interchangeably with brand J. The calibration curve for reference Cefuroxime Axetil at 280 nm was linear over a concentration range of 0.00-10.00μg/ml. The variation of absorbance with concentration showed excellent correlation with coefficient of correlation (r) of 0.9995 and coefficient of determination (r2) of value 0.999. The results of the percentage recovery of the various brands of Cefuroxime Axetil revealed that all the brands were within the USP acceptable limit of 90-110% percentage recovery for Cefuroxime Axetil. All the brands also met the BP specification of 92.5-105.0% content of active ingredient. The spectrophotometric assay of Cefuroxime Axetil based on the formation of diazo complex is cheap, sensitive, with instantaneous colour-development and readily applicable. Therefore, it can be useful in quality control and routine analysis of Cefuroxime Axetil.

Keywords: Cefuroxime Axetil, Qualitative assay, Spectrophotometric assay, diazo complex.