Abstract

Stability indicating HPLC method for the quantification of fingolimog hydrochloride and its related substances*

Author(s): Narasimha Reddy Kotla*, Nagaraju Ch VS, Rajan ST, Eshwaraiah S, Sampath Kumar Reddy G, Rakesh M, Seetha Rama Sarma P, Kishore M and Chakravarthy IE

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Fingolimod hydrochloride drug substance. The method was optimized using buffer (prepared by dissolving 2.72gr KH2PO4 and 2.0gm 1-Octane sulphonoic acid sodium salt anhydrous taken in 1000mL milli-Qwater and then pH was adjusted to ~ 3.0 with dilute orthophospharic acid solution) as mobilephase-A, and Acetonitrile: water in the ratio of 90:10 v/v as mobile phase-B. The flow rate was set at 1.2 mL min-1, wavelength at 220nm respectively and the column temperature was maintained at 45°C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.

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