AQbD Approach- RP-HPLC Method for Optimization, Development and Validation of Garenoxacin Mesylate in Bulk and in Tablets

[摘要] Garenoxacin Mesylate (GRN) is a quinolone antibacterial agent for the management of bacterial illness. The established method illustrates a development of simple, specific and robust method for the analysis of GRN using a reversed phase high-performance liquid-chromatography method on PrincetonSPHERE ULTIMA C18 column (250 mm x 4.6 mm, 5 μm) with PDA detection was carried out at 280 nm. A seven-factor eight-run Taguchi design was applied to factor screening studies and central composite design with α = 1 was utilized to optimization of experimental parameters of RP-HPLC for obtaining anticipated chromatographic resolution. Risk assessment, examine was executed to understand the basic method parameters. From the risk assessment three independent parameters such as percent acetonitrile content, mobile phase pH and flow rate were selected and study the impact of these parameters on the responses. From the design information the optimized chromatographic conditions comprises of acetonitrile: water in the ratio of 60:40 % v/v, pH 3.5 of aqueous phase marked using 0.1 % ortho phosphoric acid, separately. The percent recovery study was executed at three levels, was obeyed in the range of 99 - 101 %. Additional the method was validated as per ICH guidelines.

[学科分类] 分析化学

[关键词] Garenoxacin Mesylate;Analytical Quality by Design (AQbD);Central Composite Design (CCD);method development;validation