Rp-HPLC Analytical Method Development and Validation for Quantitative Estimation of Itopride Hydrochloride in Solid Oral Formulations

The present study was aimed at the development and validation of a simple, rapid, precise, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of Itopride Hydrochloride in tablet dosage forms. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of potassium dihydrogen phosphate buffer and methanol (60:40, v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 220 nm using a UV detector. The retention time of Itopride Hydrochloride was found to be approximately 5.84 minutes, enabling rapid analysis. The method was validated according to ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, sensitivity, and system suitability. The method exhibited excellent linearity over the concentration range of 50–150%, with a correlation coefficient (R²) of 0.9998. Accuracy studies showed mean recovery of 100.24%, while precision studies demonstrated low %RSD values below 0.5%, indicating excellent repeatability and reproducibility. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.32 µg/mL and 1.08 µg/mL, respectively, confirming the sensitivity of the method. Robustness studies revealed that minor deliberate changes in chromatographic conditions did not significantly affect analytical performance. Forced degradation studies under acidic, alkaline, oxidative, and thermal stress conditions demonstrated that the method could effectively separate degradation products from the main drug peak, confirming its stability-indicating nature. The developed RP-HPLC method was found to be accurate, precise, robust, sensitive, and suitable for routine quality control analysis and stability studies of Itopride Hydrochloride in pharmaceutical dosage forms.