HPLC BASED PROCEDURE DEVELOPMENT FOR MONITORING ACETIC ACID IN DACLATASVIR DRUG

Abstract

A process for determination of acetic acid (AAD) in Daclatasvir (DAC) active medicinal ingredients applying HPLC technique was developed. The process involved separation AAD using Phenomenex made Synergi polar RP-80A column with gradient manner of elution, employing mobile solvent phase with 0.1% phosphoric acid (solvent A) and acetonitrile (solvent B), at flow velocity of 0.6 ml/min and UV sensor examination at 210 nm. AAD linearity range was 5.01289μg/ml to 30.07733μg/ml with sensitivity of 1.65425μg/ml (LOD) and 5.01289μg/ml (LOQ). Accuracy towards AAD recoveries were 111.3 to 113.0%, 86.7 to 94.4% and 90.9 to 95.7%, and precision towards AAD’s RSD was 1.197% and 3.367%. The projected HPLC process could be applied to analysis of AAD in DAC active medicinal ingredients with sharp selectivity, better sensitivity, and high point accuracy.