HPLC analysis of drugs according to pharmacopoeia

In the pharmaceutical industry, the specifications of the respective pharmacopoeias are highly important. The aim of the pharmacopoeias is to ensure consistent and uniform quality standards of starting materials and medicinal products, and thus safe use for patients, by means of legally binding regulations.
One of the most important pharmacopoeias are the United States Pharmacopoeia (USP) and the European Pharmacopoiea (EP). Often drugs and their impurities are determined by HPLC. The monographs describe the stationary and mobile phases and specify the other chromatographic conditions, such as column temperature, injection volume, and so on. The permissible deviations from the methods without requiring revalidation of the entire method are also regulated in the pharmacopoeias. In the following video you will find an overview about changing method parameters according to EP and USP.

Examples of HPLC analysis according to EP and USP with successful method optimization

In a series of application notes the separation of pharmaceuticals from impurities according to EP/USP using NUCLEODUR C18 Gravity HPLC columns, NUCLEOSIL 100-5 C18 HPLC columns (both fully porous particles) or NUCLEOSHELL RP 18 HPLC columns (superficially porous particles) is described. Also the advantages of method optimization within allowable adjustments are shown.