Method Development and Validation of Cefpodoxime Proxetil and Ofloxacin in Individual and Combined Dosage Form

Abstract

Four simple, accurate, sensitive and reproducible methods are described for the quantitative determination of Cefpodoxime Proxetil(CP) and Ofloxain(OFLO) in their individual and combined dosage form. The first method involves UV Spectrophotometric method for the simultaneous estimation of CP and OFLO in bulk and tablet dosage form. The solvent used was 6 M urea and the absorption maxima for CP and OFLO were found to be 234nm and 286nm respectively.The two drugs follows the Beer- Lambert’s law over the concentration range of 3-30 µg/ml. The second method involves the Spectrofluorimetric method includes synchronous mode estimation of ofloxacin in bulk and tablet dosage form using delta value 140 (medium sensitivity mode) that involves measurement of fluorescence intensity at 480 nm synchronous spectra of OFLO drug. Linearity range was observed in the concentration range 0.05-1 µg/ml.The third method is based on separation of drugs by HPTLC followed by densitometric measurements of their spots at 290 nm. The separation was carried out on HPTLC aluminium sheets of silica gel 60 F254 using Chloroform: Ethyl acetate:MeOH:TEA (5.0:0.75:0.5:0.3 v/v/v/v) as mobile phase. The linear regression analysis was used for the regression line in the range of 500 -2000 ng/spot for CP and OFLO. This system was found to give compact spots for CP and OFLO, after development. The fourth method is based on SFC separation of CP on the C18 column (150 mm length, 4.6 mm i.d, 5 µm particle size) & Agilent ZORBEX SB Phenyl column (150 mm length, 4.6 mm i.d, 5 µm particle size) at ambient temperature using a mobile phase consisting of CO2 and methanol use as modifier.Condition was optimize by changing flow rate and backpressure.The oven temperature was kept at 350C.The detection wavelength was 237 nm.The develop method validated for various parameter and all were found within acceptance criteria.