Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gatifloxacin and Loteprednol Etabonate in Pharmaceutical Dosage Form

A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Gatifloxacin (GTF) and Loteprednol etabonate (LTP) in ophthalmic suspension. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0): Acetonitrile (65:25:10 v/v/v) with flow rate 1.0 ml/min using PDA detection at 264 nm. The column used was Phenomenex C18, (150 mm x 4.6 mm i.d., 5 μm). The method was linear over a concentration range 2 - 35 μg/ml for both drugs. The retention time of Gatifloxacin and Loteprednol etabonate were found to be 2.31 min and 5.36 min, respectively. Results of analysis were validated statistically. The mean recovery was 100.73 ± 1.11 and 99.74 ± 0.69 for GTF and LTP, respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for GTF and LTP were found to be 0.103 and 0.312 μg/ml and 0.118 and 0.360 μg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine analysis of GTF and LTP in pharmaceutical dosage form