Development and Validation of Spectrophotometric Method for Simultaneous Determination of Cefpodoxime Proxetil and Ofloxacin in Tablets

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of cefpodoxime proxetil and ofloxacin in combined tablet dosage form. The method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. Cefpodoxime proxetil has absorabance maxima at 236 nm and ofloxacin has absorbance maxima at 299 nm in methanol. The linearity was obtained in the concentration range of 5-29 μg/ ml and 1-13 μg/ml for cefpodoxime proxetil and ofloxacin respectively. The concentrations of the drugs were determined by using simultaneous equations at both the wavelengths. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The suitability of this method for the quantitative determination of cefpodoxime proxetil and ofloxacin was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of cefpodoxime proxetil and ofloxacin in pharmaceutical dosage form. The result of analysis has been validated statistically and by recovery studies. INTRODUCTION: Cefpodoxime proxetil (CPD) (Figure 1) is chemically, 1-(isopropoxy carbonyloxy) ethyl (6R, 7R)-7-[2(2-amino4thiazolyl)(z)2(methoxyimino) acetamido]-3-methoxymethyl-3-cephem-4-carboxylate , is a third generation cephalosporin antibiotic. It is used for infections of the respiratory tract, urinary tract and skin and soft tissues . Cefpodoxime proxetil is official in IP and USP. IP 3 and USP 4 describe liquid chromatography method for its estimation. Literature survey reveals HPTLC 5 method for the determination of CPD. Literature survey also reveals RPHPLC 6 and spectrophotometric 7 methods for determination of CPD with other drugs. Ofloxacin (OFL) (Figure 2) is chemically, 9-fluro-2-3 dihydro-3-methyl-10-(4-methyl 1piperazinyl) 7oxo7Hpyrido [1, 2, 3-de] 1, 4benzoxazine-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 11 and USP 4 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 15 methods for determination of OFL with other drugs. The combined dosage forms of CPD and OFL are available in the market and used in Urinary