Abstract
Many reports published in print and electronic media about the presence of substandard drugs in the local market of Pakistan which confuse the health care professionals. Therefore, the present study was aimed on pharmaceutical quality evaluation of different brand of Cefadroxil monohydrate manufactured by local and multinational companies of Pakistan. Study design was cross sectional and conducted at Institute of Pharmaceutical and Environment Research, Dow University of Health Sciences, Karachi during the month of September’2012 through Octtober’2012. Different pharmaceutical parameters, weight variation, thickness, hardness, disintegration time, dissolution testing and chemical assay were performed on all formulations of Cefadroxil monohydrate. These tests were performed as specified in United State Pharmacopeia (USP 28). Non pharmacopeia test (dissolution profile) was also performed to observe the drug release from dosage forms. Stastical test ANOVA was adopted to compare dissolution profile and chemical assay of Cefadroxil monohydrate from different brands using SPSS 20.0. Results of weight variation, thickness and hardness tests for all the samples were within the specified limit. The disintegration time for all the samples was within the range of 1.0 to 4.0 minutes. The dissolution test was passed for all samples analyzed during the study except one which passed in S-2 test limits according to USP. Percent dissolution in 30 minutes was in between 86.48 and 101.15%. F2 similarity results revealed that only three brands showed similarity in dissolution profile with that of reference brand, whereas, f2 factor for one brand was far from the FDA criteria (i.e. 50-100). Assay results of all samples were in the range of 95-118% of the label claim of Cefadroxil monohydrate. It is concluded that all the brands of Cefadroxil monohydrate are of good pharmaceutical quality. The pharmaceutical quality of local and multinational brands was comparable.