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

Phenomenex Inc

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

17 Mar 2016

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.

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. PurificationPurification techniques are essential for isolating compounds of interest from complex mixtures, such as proteins, nucleic acids, and chemicals. These techniques are critical in biochemistry, drug development, and environmental studies. Explore purification systems in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Chiral CompoundsPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.USP Method

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