ファーマシューティカ アナリティカ アクタ

概要

Simultaneous Determination of Gatifloxacin and Ambroxol Hydrochloride in a Tablet Formulation by Liquid Chromatography

Lakshmana Prabu S, M. Srinivasan, S Thiagarajan and Queeni Marina

A rapid and accurate liquid chromatographic method has been developed for the simultaneous determination of gatifloxacin (GFC) and ambroxol hydrochloride (AMB) in a tablet formulation. Chromatographic separation of the two drugs was achieved on a Phenomenex column (200mm×4.6 mm, 5μm). The mobile phase consisting of a mixture of 0.1 M phosphate buffer adjusted to pH 5.5 and acetonitrile in the ratio of 55:45 was delivered at a flow rate of 1.0 ml/ min. Detection was performed at 254 nm using UV detector. The retention time for GFC was around 2.2 and AMB was around 4.5 min; separation was complete in less than 10 min. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 10 – 200 μg/ml and 10 – 100 μg/ml and correlation coefficient was found to be 0.9992 and 0.9983 for GFC and AMB respectively. The method was validated for accuracy, precision and recovery studies. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of GFC and AMB. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quality control of formulation products.