Pharmaceutical evaluation of cefuroxime axetil tablets available in drug market of Pakistan

Abstract

Cefuroxime is a second generation cephalosporin antibiotic with a broad spectrum activity against Gram positive and Gram negative bacteria. The purpose of this research work was to evaluate the pharmaceutical quality standards of four different brands of cefuroxime axetil 125 mg tablets with different price ranges purchased from retail pharmacies of Pakistan. The brands were tested for physicochemical evaluation and in vitro dissolution studies in different medium like 0.07N HCl, distilled water, 0.1N HCl of pH 1.2 and phosphate buffers of pH 4.5 and pH 6.8. Statistical analysis, model dependent (zero order, first order, Korsmeyer-Peppas, Hixson-Crowell, Weibull) and model independent (Difference f1, similarity f2) approaches were applied to multiple dissolution profile of all brands. All brands were found to be similar with reference and meeting the compendial quality standard. Inter brand variation was observed in disintegration time and assay which was resulted in significant differences (P<0.05) in drug release data and Weibull was observed as best fill model.

Comparative Quality Evaluation of Selected Brands of Cefuroxime Axetil Tablets Marketed in the Greater Accra Region of Ghana

“…All the sampled brands had their dimensions (length, thickness, and width) within the stipulated range of ±5% (Table 2) and hence conformed to specifications. ese indicate that there was consistency in the manufacturing variables such as compression force, filling of the die cavity, lower and upper punch movements, and die volume [22,27]. 4.5.…”

“…e bottom of the basket rack was positioned such that it was at least 15 mm below the surface of the distilled water and the experiment was conducted at 37°C ± 2. e disintegration time was taken to be the time no granule of any tablet was left on the mesh. ree determinations were done and the mean disintegration time was determined for each brand [21][22][23].…”

“…Ten milliliters of the filtrate was diluted to 100 ml with methanol, and after serial dilutions, the absorbance of the resulting solution was measured at a wavelength of maximum absorption 276 nm. e content of cefuroxime axetil was then calculated using the previously determined calibration curve (y � 0.09x + 0.064, r 2 � 0.997) [22][23][24].…”

“…A plot of the cumulative drug release against time was then used to obtain the dissolution profile. is was done for all the sampled brands [22,24].…”

“…Friability and hardness tests help to assess the ability of a tablet to withstand abrasion that is usually associated with packaging, handling, and transportation. ese tablet properties are mainly influenced by the nature and amount of the binder usually used and force of compression [22]. From the results obtained (Table 2), all the brands passed the friability and hardness test indicating that the force of compression, type of binder, and its concentration were adequate [21,29].…”