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

Abstract

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.