Abstract

A VALIDATED HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR ESTIMATION OF FINGOLIMODHYDROCHLORIDE CAPSULES

Nagarapu Kalyani*, Dhanalakshimi and Nagarjuna Reddy

ABSTRACT

A rapid, simple, precise, Cost-effective reverse phase high performance liquid chromatographic (RP-HPLC) method had been developed and validated for the estimation of Fingolimod Hydrochloride in bulk pharmaceutical dosage form. The chromatographic separation of Fingolimod Hydrochloride was developed on a Reverse phase phenomenex Luna 5μ C8 (250× 4.6 mm i.d).using UV detection at 221nm. Mobile phase consisting of 0.1 % Triethylamine (pH adjusted to 7.05 with 0.1 % Orthophosphoricacid: Methanol (40:60 v/v), with flow rate was 0.8ml / min. Chromatogram showed the main peak at a retention time of 3.04 ± 0.02 min. The linearity was found in the concentration range of 4.1-12.3 μg/ml. The Correlation coefficient was 0.9994. The limit of detection and limit of quantitation for estimation of Fingolimodwas found to be 0.043 (μg/ml) and 0.13 (μg/ml) respectively. Recovery of Fingolimod Hydrochloride was found to be in the range of 999.9-100.62 %. The Proposed method can be used for the routine analysis of Fingolimod in Capsule dosage form.

Keywords: Fingolimod Hydrochloride, Method development, validation, RP-HPLC, ICH guidelines.