Stability indicating chromatographic method transfer of immunomodulating drug fingolimod from high performance liquid chromatography to new generation ultra performance liquid chromatography with comparative validation study

Abstract

The simplest, sensitive, less solvent consuming and time saving stability indicating reverse phase isocratic chromatographic separation method of Fingolimod has been performed on High performance liquid chromatography (HPLC) system as well as a new generation high resolution equipment is that Ultra performance liquid chromatography (UPLC) as per international conference on harmonization guidelines. Chromatography separation was carried out on an UPLC system by using acquity BEH C18 column (100 x 2.1 mm, particle size 1.7 μm) and sunfire C18 column (250 x 4.6 mm, particle size 5.0 μm) was used for HPLC system. The mobile phase for ultra performance liquid chromatography consisted of Buffer: Acetonitrile (35: 65 v/v) with a flow rate of 0.35 ml/min, whereas for high performance liquid chromatography same mobile phase have been used with a same composition, but flow rate was differ is that 0.9 ml/min. The detection was achieved at 220 nm for both instruments. The stability indicating method was confirmed by applying various stress conditions like acidic, basic, oxidative, thermal and photolytic as per ICH recommendations. The different validation parameters have been performed on both chromatographic equipments and compared with each other. By comparison of validation data of both instruments we found that UPLC system is much more accurate, precise, sensitive, robust and time saving equipment.