Development and Validation of RP-HPCL Method for Simultaneous Estimation of Memantine Hydrochloride and Donepezil Hydrochloridein Tablet Dosage Form Using Opa-B-Mercaptoethanol Pre-column Derivatization

Abstract

A simple, specific, accurate reversed phase liquid chromatographic method was developed for the determination of MEM and DH in their pharmaceutical dosage forms. The proposed methods include derivatization of MEM with OPA-βmercaptoethanol due to lack of chromophoric group. the chromatographic separation achieved by injecting 20 μL of the mixture into a JASCO HPLC system with photodiode array detector using a ACE C18 column(150 mm×4.6mm i.d., 5μm).The mobile phase consisting of 80% acetonitrile and 20% phosphate buffer (pH-7) solution and a flow rate of 1.0 mL/min. The MEM and DH was eluted respectively at 8.6 and 3.5 minutes and PDA detection at 326 nm. The linearity was in the range of 5-25 μg/ml with R2 0.9988 and 0.9997, respectively for MEM and DH.dosage forms of MEM and DH were successfully analyzed using the developed method. High percentage recovery shows that there is no interference of excipients in the dosage form. The developed method was found to be selective and rapid for simultaneous estimation of MEM and DH in their combined dosage forms.