Optimized and validated RP-HPCL method for the estimation of ethosuximide in pure and pharmaceutical formulation: evaluation of green and white analytical chemistry principles

Abstract

The aim was to develop and validate a coherent and sustainable reverse-phase high-performance liquid chromatographic method for the quantification of Ethosuximide in oral solution. The partitioning was achieved using a stationary phase Shimpak solar C18 column (4.6 × 250 mm, 5 μm) with the mobile phase (60% acetonitrile and 40% water), flow rate (1 mL/min) and wavelength (210 nm). The developed method was validated as per ICH Q2R1 guidelines. The optimized method was evaluated for greenness and whiteness using analytical tools: AES, AGREE, MoGAPI, BAGI, RAPI, RGB fast models and compared to the reported methods. Ethosuximide was eluted at 3.445 min. The method was linear at 10-70 μg/mL with r2 = 0.9995. All the validation parameters were within the accepted values. The projected HPLC method met the requirements for effectiveness, greenness, efficiency, analytical performance, and productivity in terms of green and white analytical chemistry principles. Moreover, the optimized and validated analytical method was significantly better compared to the two reported methods on the basis of analytical performance, eco-friendliness and throughput. The results of the developed analytical method are reproducible, efficient with excellent chromatographic properties and effectively employed for regular quality assessment of Ethosuximide in oral solution. Keywords: Green and White analytical chemistry; Ethosuximide; Validation; Sustainability; ICH Q2R1