Abstract

DEVELOPMENT AND VALIDATION OF SPECTROFLUORIMETRIC METHOD FOR THE ESTIMATION OF PAZUFLOXACIN MESYLATE IN PHARMACEUTICAL DOSAGE FORM

Mitesh R. Gaonkar* and Teja V. Walke

Abstract

A simple, sensitive, rapid, precise, accurate & robust spectroflourimetric method has been developed for estimation of Pazufloxacin Mesylate in its pure and pharmaceutical dosage form. Pazufloxacin Mesylate showed good fluorescence intensity in 0.2N HCl and so 0.2N HCl was selected as a solvent for estimation of Pazufloxacin Mesylate by spectroflourimetric method. The optimized excitation (λex) and emission (λem) wavelength were 251 nm and 418 nm respectively with 5nm slit width for Pazufloxacin Mesylate determination. The calibration curves were found to be linear between fluorescence intensity and drug concentration in the range of 8-48 ng/ml with coefficients of determination above 0.994 for the analyte. The method recoveries were higher than 98%. The limit of detection (LOD) and limit of quantitation (LOQ) were found in the range of 0.4803 ng/ml and 1.4556 ng/ml respectively. The % RSD values of intra- and interday variation coefficients were observed less than 2%. The developed method was validated in terms of linearity, precision, accuracy, limit of detection and limit of quantitation, robustness as per International Conference on Harmonization Q2 (R1) guidelines.[1] This method is simple, accurate and rapid therefore can be used for routine analysis of Pazufloxacin Mesylate in quality control laboratories.

Keywords: Spectrofluorimetric; Pazufloxacin Mesylate; Fluorescence; Excitation; Emission; Validation.