Determination of Bulk Drug Purity and Tablet Potency Using Capillary Zone Electrophoresis
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The purpose of this project is to develop methods to determine the purity of a bulk drug and the potency (that is, the amount of active ingredient present) of drug tablets and capsules. Currently, Upjohn is testing 3-guanidinopropionic acid (3-GPA, referred to internally as U-10,483) in clinical trials. This pharmaceutical is for the treatment of non-insulin dependent diabetes mellitus or Type II diabetes. A second possible indication for this drug is obesity. A quantification scheme for this pharmaceutical has already been developed using ion-pairing reversed phase high performance liquid chromatography. High performance capillary electrophoresis, or capillary zone electrophoresis (HPCE or CZE) has become an increasingly common analytical technique in the pharmaceutical industry. There is wide spread application of this technique in the areas of biotechnology, or more specifically in the separation of proteins, peptides and DNA fragments. At the same time, this technique is becoming increasingly employed for the separation of small molecules.