A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Gatifloxacin sesquihydrate (GAT) and Prednisolone acetate (PRD). The method showed adequate separation for Gatifloxacin sesquihydrate (GAT) and Prednisolone acetate (PRD) and best resolution was achieved with ACE 5 C18 column (150 mm x 4.6 mm i.d., 5 µm particle size) using Acetonitrile-Phosphate buffer pH 3-Methanol (30:50:20, v/v; pH adjusted to 3 with O-phosphoric acid and TEA (Tetra ethyl amine) as a mobile phase at a flow rate of 1.0 ml/min and wavelength of 267 nm. The calibration curves were linear over the concentration ranges of 2-30 μg/ml for Gatifloxacin sesquihydrate and 4-35 μg/ml Prednisolone acetate. The limit of detection (LOD) for GAT and PRD were found to be 0.69 µg/ml and 0.52 µg/ml, respectively. The limit of quantification (LOQ) values for GAT and PRD were found to be 2.09 µg/ml and 1.57 µg/ml respectively all the analytes were separated in less than 6.0 min. The proposed method could be applied for routine laboratory analysis of Gatifloxacin sesquihydrate and Prednisolone acetate in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.
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