Analysis of Fingolimod Hydrochloride according to the USP monograph 1745

Introduction

United States Pharmacopeia (USP) establishes analytical methods needed for the identity, purity, quality, strength, and potency of drug products, food ingredients, and dietary supplementary products. USP also provides reference standards that are needed for these methods. These reference standards and methods are used by manufacturer and regulatory agencies to ensure the identity, purity, quality, strength and potency of the products produced. Here, we introduce an example of gradient analysis of Fingolimod Hydrochloride monography in compliance with General Chapter 621. Fingolimod Hydrochloride is a sphingosine-derivative and immunosuppressive agent that blocks the migration and homing of lymphocytes to the central nervous system through its action on sphingosine 1-phosphate receptors. It is marketed by Novartis under the trade name GILENYA and used in the treatment of multiple sclerosis. Shim-packTM GISS C18 analytical column and Prominence^TM-i LC-2030C Plus system were employed in this application. Shim-pack GISS C18 is packed with ultra-high inert silica gel, provides only hydrophobic interaction to analytes and eliminate secondary interaction that leads to peak tailing. It tolerates a wide pH (1 – 10) condition and has excellent stability in 100 % aqueous mobile phases, making it suitable for analysis of many different compounds. Its rapid column equilibration property shortens the column equilibration time for analysis in gradient methods, giving reproducible elution profile, lower baseline drift and sensitivity.

March 23, 2020 GMT