Development and validation of RP-HPLC for estimation of efonidipine hydrochloride ethaolate in pharmaceutical formulation

Efonidipine hydrochloride ethanolate is a dihydropyridine calcium channel blocker used to treat hypertension. It's a third-generation calcium channel blocker, also known as NZ-105, that blocks both T-type and L-type calcium channels. It's known for its slow onset and long duration of action. Efonidipine hydrochloride ethanolate is a solvate, meaning it's a compound formed by the combination of efonidipine hydrochloride and ethanol in an equimolar ratio. Its molecular formula is C36H45ClN3O8P, and its molecular weight is 714.19 g/mole. The aim of the present study is to develop and validate the RP-HPLC method for estimating Efonidipine hydrochloride ethanolate in Pharmaceutical Dosage Form, focusing on the application of suitable analytical techniques, optimization, and validation in accordance with ICH guidelines, while selecting the appropriate drug and developing an analytical methodology. In this study, we found that the pharmaceutical dose tablet formulations containing Efonidipine hydrochloride ethanolate (EHE) may be accurately measured using the RP-HPLC method. The RP-HPLC technique is sensitive, accurate, precise, and repeatable; it also demonstrates high repeatability. Efonidipine hydrochloride ethanolate (EHE) tablet dosage formulation analysis may also be conducted with success. These techniques do not experience any influence from additives, matrices, etc. To further understand these trials, additional research on other medication formulations is needed.