A Two-Step Optimization Approach: Validated RP-HPLC Method for Determination of Gatifloxacin and Dexamethasone in Ophthalmic Formulation

Abstract

The growing technology of stationary phase chemistry has a great impact on the chromatographic system performance and analysis economics. In this context, a simple rapid reversed phase high-performance liquid chromatography method development is presented for the analysis of gatifloxacin (GFN) and dexamethasone sodium phosphate (DSP) in their ophthalmic formulation. A two-step optimization approach has been conducted using optimum chromatographic conditions as well as proper selection of stationary phase. The chromatographic separation was carried out using sodium phosphate buffer pH 3.0 ± 0.1 and acetonitrile 72:28 v/v, respectively, with flow rate 1 mL min−1 and simultaneous detection at 243 nm. Three different column technologies were investigated at the optimum set of the chromatographic conditions: Xbridge® bridged ethylene hybrid silica, Kinetex™ Core-Shell and the Onyx™ Monolithic stationary phase. The monolithic column has shown better chromatographic separation, based on system suitability testing as well as shorter analysis time and sensitivity. The proposed method was validated according to International Conference on Harmonization guidelines. The linearity was achieved for GFN and DSP in the range 0.58–120 μg mL−1 and 0.50–120 μg mL−1, respectively, with acceptable accuracy, precision and selectivity.

Green method by National Environmental Methods Index and Eco‐Scale Assessment for evaluation of gatifloxacin‐based product by HPLC

“…In addition, over 77% of these methods use a 250‐mm column instead of smaller columns, such as 150 or 100 mm, which generates more waste. Furthermore, over 77% of these methods use a flow rate of 1.0 mL min −1 , which contributes to more waste generation compared with smaller flow rates (Aljuffali et al, 2015; El‐Gammal et al, 2018; Gandhi et al, 2016; Grace et al, 2019; Hassan et al, 2018; Razzaq et al, 2012; Razzaq et al, 2017; Saad et al, 2020; Venugopal et al, 2007). All these choices combined impact the sustainability, cost, and environmental friendliness/greenness of the method.…”

Multiple sensitive eco‐friendly analytical approaches for the determination of two fourth‐generation fluoroquinolones: Application to stability study and content uniformity testing

“…[13] Several approaches for determining GTF have been reported such as spectrophotometry, [14,15] spectrofluorimetry, [16,17] and HPLC methods. [18][19][20] Micellar mobile phase (MLC) has recently sparked a lot of interest in liquid chromatography. Diverse types of interactions including hydrophobic, electrostatic, and steric exist between the solute and both the mobile and stationary phases were afforded.…”

Green versatile micellar electrokinetic chromatographic method for determination of six antimicrobial and anti-inflammatory drugs in combined dosage forms

“…The recent articles concerning the analysis of CIP include spectrophotometric [11,12], High performance liquid chromatography (HPLC) [13,14] and capillary electrophoresis (CE) [15,16] methods. Regarding DXM, the recent methods include spectrophotometric [17], TLC [18], HPLC [19,20] and CE [21] methods. For MNZ, the reported methods include spectrophotometric [22,23] electrochemical [24,25], TLC [26,27] HPLC [28,29] and CE [30,31] methods.…”