Abstract

A VALIDATED VISIBLE SPECTROPHOTOMETRIC ASSAY OF GATIFLOXACIN IN BULK AND TABLET DOSAGE FORMS USING FE(III) IN BUFFER MEDIA

P. Ramanna, B. Saritha*, and Prof .T. Sreenivasulu Reddy

ABSTRACT

Gatifloxacin and Fe(III) react in the pH range 1.0-4.0 to form a yellow colored complex solution. Its absorption spectrum shows maximum absorbance at 400 nm. The absorbance is constant and maximum in the pH range 2.0-3.0. pH 2.5 is selected for analytical studies. The absorbance of the complex solution varied linearly with the amount of gatifloxacin. A plot of the amount of gatifloxacin and the absorbance at 400 nm is linear and obeys the equation A400 = 0.0395 C + 0.0017. The linear plot shows that Beer’s law is obeyed in the range 1.5-32.0 μg/ml of gatifloxacin. The molar absorptivity is 1.44 x 104 l mol-1 cm-1. The sandell’s sensitivity is 0.0252 μg cm-1. The standard deviation of the method for ten determinations of 10 μg/ml of gatifloxacin is 0.0018. The correlation coefficient () is 0.9999. The effect of excipients that are generally associated with gatifloxacin in pharmaceutical dosage forms is investigated. The proposed visible spectrophotomeric method was validated as per ICH guidelines. The validation parameters such as, linearity, accuracy, precision, LOD, LOQ and ruggedness were investigated. The method is simple, rapid, precise, selective and accurate. The present method was applied for the determination of gatifloxacin in its tablet dosage forms.

Keywords: Gatifloxacin, Fe (III), Visible Spectrophotometry, Method validation, Buffer mediam.