Development of GC Method for Analyzing Potential Genotoxic Impurities at Low-level Determination in Atorvastatin Calcium

Abstract

Atorvastatin Calcium (ATC) is a specific HMG-CoA reductase inhibitor utilized in the avoidance and treatment of cardiovascular infection in those at high danger and treat strange lipid levels. For the quantitative analysis of four PGIs in the medicine ingredient ATC, an ICH-approved Gas chromatography (GC) approach has been developed. Within the examined fixation range, the novel approach was explicit, exact, precise, and direct. Pollutant D, with 0.6 ng/mL, had the lowest recognition level among the four PGIs, which were all below 10 ng/mL. Every contaminant from ATC has been effectively chromatographically separated into its component parts. At a low level, ATC's technique was found to be highly effective in terms of pollution reduction. Proposed techniques are relied upon to measure the strength of ATC creation and to examine PGIs as a reference for ATC assessments. This method can be used to check for pollution levels in the manufacturing process of pharmaceuticals. The API's PGI levels will be kept low thanks to the GC's oversight. As a result, this study's findings will help ensure the safe use of APIs during clinical therapy.