Simultaneous Method Development and Validation of Esomeprazole and Itopride in Bulk and Dosage Forms by RP-HPLC Method

The study's primary goal was to create and validate an RP-HPLC method for determining the pharmaceutical dose form and bulk levels of esomeprazole (ESO) and itopride (ITO). The linearity data was obtained in the concentration range of 12µg/mL to 28µg/mL for esomeprazole and 45µg/mL to 105µg/mL foritopride. Trails were conducted to optimize various parameters such as wave length, column, mobile phase ratio etc. The optimized parameters were ODS C18 Inertsil 250 x 4.6mm, buffer: methanol: acetonitrile (ACN)(30:40:30) v/v/v. Optimal detector response for the drugs was achieved at a detection wavelength of 215nm, and the developed methods were verified for specificity, accuracy, precision, sensitivity, robustness, and ruggedness. All parameters met the specification limits as outlined in the ICH guidelines. From linearity response of Esomeprazole and Itopride R2 was calculated as 0.9974 and 0.9981. Esomeprazole and Itopride had retention times (RT) of 4.4min and 2.5min respectively. The developed method can be employed for quality control checks for the pharmaceutical dosage forms.