Development and Validation of Spectrophotometric Method for Simultaneous Determination of Prednisolone Acetate and Ofloxacin in Eye-drop

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of prednisolone acetate and ofloxacin in combined eye drop dosage form. The method is based on the simultaneous equations method for analysis of both the drugs using methanol as solvent. Prednisolone acetate has absorbance maxima at 243 nm and ofloxacin has absorbance maxima at 228 nm in methanol. The linearity was obtained in the concentration range of 5-17 μg/ ml and 1-13 μg/ml for prednisolone acetate and ofloxacin respectively. The concentrations of the drugs were determined by using simultaneous equations method at both the wavelength set 243nm for PRD and 228nm for OFL. The method was successfully applied to pharmaceutical dosage form because no interference from the eye-drop excipients was found. The suitability of this method for the quantitative determination of prednisolone acetate and ofloxacin was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of prednisolone acetate and ofloxacin in pharmaceutical dosage form. The result of analysis has been validated statistically and by recovery studies. INTRODUCTION: Prednisolone acetate (PRD) (Figure 1) is chemically, 11β 17,21-trihydroxypregna-1,4diene3,20-dione 21-acetate’, is a hydrocortisone type corticosteroid . It is used for infections of the eye . Prednisolone acetate is official in B.P. 3 and E.P. BP and E.P. describe liquid chromatography method for its estimation. Literature survey reveals RP-HPLC 4, 5 and spectrophotometric. methods for determination of PRD with other drugs. Ofloxacin (OFL) (Figure 2) is chemically, 9-fluro-2-3 dihydro-3-methyl-10(4-methyl 1-piperazinyl)-7-oxo7Hpyrido [1, 2, 3-de] 1, 4 benzoxazine-6-carboxylic acid , is a fluoroquinolone antibacterial agent used in the treatment of chalmydia or chlamydophila infections including nongonococcal urethritis and in mycobacterial infections such as leprosy . It is official in IP, BP and USP. IP , BP 9 and USP describe potentiometric method for its estimation. Literature survey reveals first derivative fluorescence spectroscopy , HPLC with fluorescence detector for estimation of ofloxacin in human plasma . Literature survey also reveals spectrophotometric , RP-HPLC and HPTLC 13 methods for determination of OFL with other drugs. The combined dosage forms of PRD and OFL are available in the market and used in eye infection. Correspondence to Author: