Abstract

An ion-moderated partition chromatographic method has been developed for rapid determination of excipients in a pharmaceutical diagnostic formulation. Citrate, inositol, and gentisic acid (2,5-dihydroxybenzoic acid) are separated and analyzed using an 0.005 M sulfuric acid-acetonitrile (80:20) mobile phase with a 100 × 7.8 mm strong cation-exchange column consisting of sulfonated cross-linked styrene-divinylbenzene copolymer in the hydrogen form. Detection is by refractive index. The method has proven to be rugged for more than 100 injections over a one-year period on the same column.

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