ABSTRACT
The analysis of a pharmaceutical product for the active pharmaceutical ingredient (API) generally requires a chromatographic procedure to separate the API from degradation products and/or other interfering substances. In industrialized economies, these separations are usually effected using high-performance liquid chromatography (HPLC). The HPLC instrumentation involves relatively sophisticated technology, and proper maintenance requires skilled staff with ready access to replacement parts. In addition, HPLC separations are performed on a relatively expensive column used repetitively; the column must be protected from damage and particulate accumulations that could affect its separation characteristics. The HPLC system must also have a reliable and consistent supply of electricity; a power failure would stop the pumping of the mobile phase allowing migration of the analytes in the column, and the thermostat chambers would not be controlled.
