ISSN : 2663-2187

METHOD DEVELOPMENT AND VALIDATION OF COMBINATION PRODUCT OF ILAPRAZOLE AND ITOPRIDE BY HPLC Method

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Arjun Saraf, Santoshi Shah, Shivanand Patil
» doi: 10.48047/AFJBS.6.15.2024.7673-7723

Abstract

Itopride hydrochloride is a prokinetic drug derived from benzamide. It has been granted certificate for the treatment of symptoms associated with illnesses such as non-ulcer dyspepsia. Potential etiologies for the illness are chronic gastritis, diabetic gastroparesis, or functional dyspepsia. The main objective of this research was to investigate the process of developing pharmaceutical dosage forms using reversed high-performance liquid chromatography (HPLC). By utilizing a sophisticated validation technique, we can effectively analyze the medication in a pharmaceutical dose form using reversed-phase high-performance liquid chromatography (HPLC). Validation is an ongoing process that begins before the use of an instrument and extends much beyond the invention and transmission of a method. A novel HPLC technique was developed and validated for the analysis of itopride hydrochloride and ilaprazole sodium. The most effective chromatographic separation was accomplished by using a Phenomenex C18 column, with UV detection set at a wavelength of 268nm. The mobile phase used consisted of a mixture of ethanol, water, and acetonitrile at a ratio of 50:40:10. The retention time of itopride hydrochloride was determined as 2100, whereas the retention time of Ilaprazole sodium was reported as 6700. The retention time data of the commercially available product were compared to the most optimal ones.

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