Aniracetam and Related Impurities in Bulk Drug: Development and Validation of Stability Indicating Reversed-Phase HPLC Purity Method

Abstract

A strong semi-synthetic antiparasitic medication used in veterinary medicine is ivermectin. It is often used to treat parasites. In order to test and identify ivermectin, as well as to identify and estimate its associated compounds in bulk drug substance batches of ivermectin, this research set out to create a stability-indicating reversed-phase HPLC (RP-HPLC) approach. The goal of this project is to create a method for employing reversed-phase liquid chromatography to separate and measure aniracetam and associated contaminants in bulk medication. In order to ensure consistent quality control analyses and (tR)Retention time for related impurities, this approach is employed in the manufacture of aniracetam. The International Conference on Harmonization (ICH)'s Q1A (R2) and Q2 (R) were followed throughout the validation procedure. The HPLC technique was successfully designed, verified, and shown to be accurate, robust, specific, and stable suggesting for the analysis of ivermectin and estimate of its associated chemicals.

KEYWORD: Aniracetam, Impurities, Bulk Drug Development and Hplc Purity Method