A COMPARATIVE BIOEQUIVALENCE STUDY OF SOME BRANDS OFOFLOXACIN BY URINE AND SALIVARY ANALYSIS IN INDIA

This study was aimed to assess the bioequivalence of randomly selected brands of ofloxacin tablets marketed in India. Bioavailability assessment was conducted by measuring the concentration of drugs in the urine as well as saliva and bioavailability data was presented as cumulative quantity of drugs recovered in urine in 24 hours. Simple and sensitive, accurate and economical spectrophotometric method was developed for the estimation of ofloxacin in urine and saliva samples using phosphate buffer (pH 6.8) at 288 nm. Microbiological assay technique was used to analyze urine samples. The linearity was obtained in the concentration range of 2-20 µg/ml for ofloxacin. The two different brands of ofloxacin with the strength of 200mg and 400mg each showed same minimum inhibitory concentration value against the test strain of Staphylococcus aureus of 0.468 µg /ml and 1.388 µg /ml respectively. The salivary ofloxacin concentration ratio was highly dependent on sampling time. The salivary half-lives showed significant correlation with each other while the area under curve of ofloxacin concentration in saliva failed to show significant correlation. The two brands of ofloxacin 200mg(X1-X2), 400mg(X3-X4) each in punjab (India) exhibited same bioavailability data in vivo and can be said to be bioequivalents.