Development and Validation of HPTLC Method for the Simultaneous Estimation of Gatifloxacin and Loteprednol Etabonate in Pharmaceutical Dosage Form.

A simple, accurate, precise high-performance thin-layer chromatographic method for simultaneous estimation of Gatifloxacin (GAT) and Loteprednol etabonate (LOTE) in ophthalmic formulation has been developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as stationary phase. The solvent system consisted of methanol: ethylacetate: triethylamine (7:3:0.2v/v/v). Densitometric analysis was carried out at 272nm for LOTE and GAT. The system was found to give compact spots for LOTE and GAT at Rf value of0.70 and 0.29respectively. The linear regression analysis data showed a good linear relationship in the concentration range of 1-5µg/spot for LOTE and GAT. The% recovery was found to be 99-101% for GAT and 99-102% for LOTE. The correlation coefficient was found to be 0.999 for LOTE and GAT. The % RSD values indicated that the proposed method was precise. The specificity of the method was ascertained by peak purity profiling studies and the developed method was specific. The method has been successfully applied in the analysis of combined dosage form.