Development And Validation Of RP- HPTLC Method For Simultaneous Estimation Antibacterial Drugs from Pharmaceutical Formulation

In present study, a successful attempt was made to develop a simple, sensitive, precise and validated densitometric RP-HPTLC method for the simultaneous determination of  Ofloxacin and Cefixime from combined pharmaceutical drug formulation. Chromatographic separation was achieved on aluminium plates pre-coated with silica gel 60F254 as the stationary phase. The solvent system consisted of n- butanol: methanol: water: formic acid (8:6:4:0.3 v/v) which was found to give compact and dense spots for OFX and CFX with  Rf value 0.17 ± 0.02 and 0.50 ± 0.02 respectively. Densitometric analysis of both drugs were carried out in the absorbance mode at 293 nm. The developed method was validated and proved to meet the requirements delineated by ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness. The regression analysis data for the calibration plots showed a good linear relationship with correlation coefficient greater than 0.999 for both ofloxacin and cefixime in the concentration range of 100-300 ng/band. The LOD and LOQ for OFX were found to be 15.0 and 45.45  ng/spot respectively and for CFX , 16.16 and 50.4 ng/spot respectively. Assay results for tablet formulation were found to be 99.30 ± 0.96 % and 100.8 ± 0.98 % of label claim for OFX and CFX respectively. The validated method was successfully applied for determination of both the  drugs in their pharmaceutical formulation indicating the ability of proposed method to be used for routine quality control analysis of these drugs.