Analytical method development and validation of simultaneous estimation of rabeprazole, pantoprazole, and itopride by reverse-phase high-performance liquid chromatography

摘要

Abstract A simple, selective, rapid, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of rabeprazole (RP), pantoprazole (PP), and itopride (IP) has been developed. The compounds were well separated on a Phenomenex {C18} (Luna) column (250?mm?×?4.6?mm, dp?=?5?μm) with {C18} guard column (4?mm?×?3?mm?×?5?μm) with a mobile phase consisting of buffer containing 10?mM potassium dihydrogen orthophosphate (adjusted to pH 6.8): acetonitrile (70:30 v/v) at a flow rate of 1.0?mL/min and ultraviolet detection at 288?nm. The retention time of RP, PP, and {IP} were 5.35, 7.92, and 11.16?minutes, respectively. Validation of the proposed method was carried out according to International Conference on Harmonisation (ICH) guidelines. Linearity range was obtained for RP, PP, and {IP} over the concentration range of 2.5–25, 1–30, and 3–35?μg/mL and the r2 values were 0.994, 0.978, and 0.991, respectively. The calculated limit of detection (LOD) values were 1, 0.3, and 1?μg/mL and limit of quantitation (LOQ) values were 2.5, 1, and 3?μg/mL for RP, PP, and {IP} correspondingly. Thus, the current study showed that the developed reverse-phase liquid chromatography method is sensitive and selective for the estimation of RP, PP, and {IP} in combined dosage form.