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.

Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles

“…Recently, many publications have been reported discussing the AQbD approach to the development and optimization of HPLC methods, for the determination of either active pharmaceutical ingredient or impurities [26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. Indeed, AQbD has turned out to be a reliable and effective approach, which is reflected in these methods, because they are more robust, easily validated, and have shorter run times for the separation of the same number of analytes compared to methods developed using the one-factor-at-a-time (OFAT) approach [26].…”

Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles

“…With the AQbD approach, improved method performance with a defined area of method robustness can be accomplished. Therefore, utilization of AQbD concepts in developing liquid chromatographic methods for determining either active pharmaceutical ingredients or their impurities have flourished in recent years, as evidenced by numerous reports on their successful application [26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45]. The use of AQbD concepts in liquid chromatography method development renders these methods more robust, makes possible their facile validation, and frequently provides shorter run times for the separation of the same number of analytes compared to methods developed using the one-factor-at-a-time (OFAT) approach [25].…”