Development of a new green gas chromatographic method for the determination of zolmitriptan in pure and pharmaceutical preparations

Abstract

A simple, accurate, and environmentally friendly method for determining raw zolmitriptan (ZMT) and its dosage form (tablets) was developed and validated using capillary gas chromatography (GC). Methanol was used to prepare the solutions of the standard and the sample, and instrument parameters were optimized with a programmed temperature ramp ranging from 230 to 290 °C, achieving a total run time of 9.0 min. The retention times for Metronidazole Benzoate (MNZB), the internal standard, and ZMT were found to be 4.89 and 8.11 min, respectively. GC separation was performed with a TRB-5 capillary column (30 m × 0.25 mm, 0.25 μm) with a 0.5 μL injection in splitless mode. The calibration curve was linear when testing a range of concentrations of 6.0–80.0 μg/mL. The limits of detection (LOD) and quantification (LOQ) were determined to be 0.53 and 1.77 μg/mL, respectively, with a correlation coefficient (R²) greater than 0.999. The method proposed was efficiently applicable to analyze pure ZMT and in tablets, showing no interference from other components of the pharmaceutical preparation. Validation of the method was done per ICH guidelines, with all parameters meeting the required acceptance criteria. Additionally, evaluation of the greenness and sustainability of the GC method proposed was performed using AGREE, modified GAPI, and the RGB fast model.