PITTCON 08 Oral Session
Inline sample preparation – An effective tool for ion analysis in pharmaceutical products
Session Number 2750-4
Abstract
The determination of traces of inorganic contaminants in concentrated ionic pharmaceuticals by ion chromatography (IC) requires inline matrix elimination from the bulk of the pharmaceutical in order to avoid overloading of the analytical column. Several methods in a new monograph of the US Pharmacopeia suggest the use of a rinsing solution consisting of the IC eluent and suitable organic solvents for removing the pharmaceutical from the analytical column. However, the procedure is tedious, time-consuming and cannot be automated. Inline sample preparation is an excellent method for the determination of anions and cations in complex pharmaceutical samples. In this paper the inline sample preparation technique is applied for the determination of sodium azide in irbesartan samples. To prevent contamination of the analytical column, the filtered sample solution is passed through an anion preconcentration column that retains the azide and the pharmaceutical. After this, the preconcentration column is rinsed with a solution of 70% methanol and 30% water to remove the retained pharmaceutical. The rinse solution is passed through an anion trap column to remove any anionic impurities. The method completely complies with the guidelines of the US Food and Drug Administration (FDA). Reproducibility and recovery are excellent, and detection limits are better than those achieved by direct-injection IC with inline sample preparation. Additionally, the new inline sample preparation technique can easily be automated.
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