Liquid chromatographic methods for simultaneous quantification of fixed‐dose combinations of pantoprazole with itopride and ondansetron: Application to method greenness assessment

Abstract

AbstractTwo liquid chromatography methods are developed to quantify pantoprazole and its fixed‐dose counterparts, itopride hydrochloride, and ondansetron. The basic chromatography utilized a C‐18 column (150 × 4.6 mm × 5 μm) with a simple mobile phase of methanol: 0.01 M potassium dihydrogen phosphate buffer of pH 3.5 (80:20 v/v) with a flow rate of 1.0 ml/min. The diode array detections were performed at 273 nm (Method‐I) and 280 nm (Method‐II). The validation of parameters like linearity (R2 > 0.99), accuracy (98%–103%), precision (≤1 %), system suitability, and so forth, was found satisfactory for both methods. A risk estimation approach helped sort out method variables methanol%, pH, and flow rate and highlighted their influence on the method's robustness. The developed methods aptly quantified all the target analytes with the maximum possible recovery from combined pharmaceuticals. Assessment of the method greenness profile revealed excellent method greenness with maximal green shades in a pictogram and a greenness score of 89. The developed analytical methods are green and befitting for routine quality control of two widely used fixed‐dose combinations of pantoprazole.