Acta Pharm. 57 (2007) 221-230
Spectrophotometric determination of pefloxacin mesylate in pharmaceuticals
KANAKAPURA BASAVAIAH*, HULLIKAL CHANDRASHEKAR PRAMEELA and BANKAVADI CHIKKASWAMY SOMASHEKAR
Department of Chemistry, University of Mysore, Manasagangotri, Mysore-570 006, India
A spectrophotometric method is described for assay of pefloxacin mesylate (PFM) in bulk drug and in tablets. The method is based on back extraction of the bromophenol blue dye at pH 5.2 from the dye-drug ion pair followed by measurement of the dye absorbance at 590 nm. The working conditions of the method were investigated and optimized. Beer’s law plot showed a good correlation in the concentration range of 0.15–1.25 mg mL-1. Sensitivity indices such as molar absorptivity, limits of detection and quantification are reported. Intra-day and inter-day precision, and accuracy of the methods were established according to the ICH guidelines, and the er values were in the range of –1.7 to 1.8% with RSD values ranging from 1.0 to 1.1%. The method was successfully applied to the assay of PFM in tablet preparations with recoveries varying from 97.5 to 101.9%, with standard deviation in the range of 0.6 to 1.9. The results were statistically compared with those of the reference method by applying Student's t-test and F-test. Accuracy evaluated by means of the spike recovery method ranged from 97.0 to 106.0%, with precision better than 3%.
Keywords: pefloxacin mesylate, assay, spectrophotometry, bromophenol blue, pharmaceuticals