Analysis Of Atorvastatin As Per USP Monograph Utilizing Alliance™ iS HPLC System

By Fadi L. Alkhateeb, Paul D. Rainville

Atorvastatin, a common statin medication, is used to reduce cholesterol levels and cardiovascular risk. Its accurate analysis via High-Performance Liquid Chromatography (HPLC) is crucial for ensuring safety and efficacy. The USP monograph for atorvastatin assay presents challenges due to the volatile nature of the sample diluent, mobile phase, and lengthy analysis time. These factors can lead to fluctuations in peak areas and retention times, hindering system suitability compliance.

To address these issues, a study was conducted to investigate the impact of sample preparation and mobile phase composition on system suitability. The results indicated that using multiple vials for replicate injections and employing low vapor reservoir caps for the mobile phase can significantly improve control and reproducibility.

Access the full article to delve into the specific challenges faced in atorvastatin HPLC analysis and practical solutions to overcome them. By implementing these strategies, laboratories can enhance the reliability and accuracy of their atorvastatin assays.