Enantiomeric Purity Analysis of the Drug Product Atorvastatin on Lux® Amylose-1 According to the United States Pharmacopeia (USP) Monograph 2263

The USP establishes methods and provides reference standards used by regulatory agencies and pharmaceutical manufacturers to ensure that APIs and drug products are of the appropriate identity, strength, quality, purity, and consistency. In the case of chiral drugs, such as Atorvastatin, a chiral HPLC method is generally used to assess chiral purity. This application note reports the enantiomeric separation between Atorvastatin Calcium (the Active Pharmaceutical Ingredient) depicted in Figure 1 and Related Compound E (enantiomer of Atorvastatin) using the new Lux Amylose-1 chiral stationary phase (CSP) according to the current USP method.