ABSTRACT

A simple and accurate high performance thin layer chromatographic (HPLTC) method have been developed and validated as per ICH guidelines for estimation of Ofloxacin (OFL) and Ornidazole (ORN) in combined dosage form. The mobile phase was acetone : water : toluene : triethylamine (5.8:1.5:2:1.6 V/V) was found to be best which gave high resolution with R_f 0.25 and 0.82 for ofloxacin and ornidazole respectively. The linearity of ofloxacin and ornidazole was found to be in the range of 0.2 to 0.3 µg/mL and 0.4 to 0.8 µg/mL respectively. The coefficient of correlation (r² ) was found to be greater than 0.9948 for both the components by this method. The tablet analysis result (n = 5) were close to 100 % by HPTLC for both the components. The proposed method was found to be simple, accurate and suitable for routine quality control of marketed formulation containing these drugs.