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.

中文翻译：

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两步优化方法：RP-HPLC验证方法，用于眼科制剂中加替沙星和地塞米松的测定。

固定相化学的不断发展的技术对色谱系统的性能和分析经济性具有重大影响。在此背景下，提出了一种简单的快速反相高效液相色谱方法，用于分析其眼科制剂中的加替沙星（GFN）和地塞米松磷酸钠（DSP）。两步优化方法已经使用最佳色谱条件以及作为固定相的适当选择进行。分别使用pH 3.0±0.1的磷酸钠缓冲液和乙腈72:28 v / v进行色谱分离，流速为1 mL min ^-1并在243 nm同时检测。在最佳的色谱条件下研究了三种不同的色谱柱技术：Xbridge®桥联乙烯杂化硅胶，Kinetex™核-壳和Onyx™整体固定相。基于系统适用性测试，整体柱表现出更好的色谱分离效果，以及更短的分析时间和灵敏度。根据国际协调大会指南对提出的方法进行了验证。线性是在范围0.58-120微克为GFN和DSP实现毫升^-1和0.50-120微克毫升^-1，分别与上可接受的准确度，精度和选择性。