Pharmaceutical Analysis

Analysis of Fingolimod Hydrochloride According to USP Monograph Guidelines

This article from Issue 10 of the Analytix Reporter, produced by Merck, demonstrates a rapid, accurate, and simple method that was developed for the total chromatographic purity analysis of Fingolimod hydrochloride by HPLC-DAD, well within the boundaries of the USP43-NF38 monograph methods. 

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FingolimodIn this article, a rapid, accurate, and simple method is presented for the total chromatographic purity analysis of fingolimod hydrochloride using High Performance Liquid Chromatography equipped with a Diode Array Detector (HPLC-DAD). The experimental conditions follow guidelines, with minor, but allowed modifications from the USP43-NF38 monograph methods for the assay and organic impurity profiling of fingolimod hydrochloride. Using the 33-minute gradient method from USP and a Purospher® STAR RP-18 HPLC column (150 x 3.0 mm, 3 µm), baseline separation of fingolimod and its impurities was achieved. A 0.1% solution of phosphoric acid in water and acetonitrile were used as the mobile phase for the gradient elution.

Experimental
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Conclusion
A rapid, accurate, and simple method for the total chromatographic purity analysis of Fingolimod
hydrochloride by HPLC-DAD was developed, well within the boundaries of the USP43-NF38 monograph methods. The applied conditions met the system suitability criteria, and the method demonstrated good resolution/selectivity, reproducibility, and sensitivity.

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*The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

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