Development and Validation of HPLC Method for the Simultaneous Estimation of Satranidazole and Gatifloxacin in Tablet Dosage Form

A simple, precise, accurate and precise reverse phase high performance liquid chromatographic method has been developed and validated for the estimation of satranidazole and gatifloxacin simultaneously in combined dosage forms. A Lichrospher 100 C-18 and mobile phase comprises of Water: Acetonitrile: Triethylamine (75:25:0.35, v/v/v) were used for separation. Final pH was adjusted to 3.2 ± 0.02 with 10% v/v o-phosphoric acid. Measurements were made at the effluent flow rate of 1.0 ml/min with injection volume 20 μl and ultraviolet (UV) detection at 320 nm, as both components shows reasonable good response at this wavelength. The retention times of satranidazole and gatifloxacin were 6.0 min and 3.44 min, respectively. The method was validated in terms of linearity, accuracy, precision, robustness and specificity. Linearity of satranidazole and gatifloxacin was in the range of 1-70 μg/ml and 1-70 μg/ml, respectively. Average percentage recoveries obtained for satranidazole and gatifloxacin were 99.80 % and 100.20 %, respectively. The limit of detection and limit of quantification were found to be 0.3 and 1.0 mg/ml for satranidazole, respectively and for gatifloxacin were 0.5 and 1.0 mg/ml, respectively. The method is useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.