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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 10
First page : ( 4547) Last page : ( 4552)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00832.6

A New stability indicating liquid chromatographic method for the quantification of Fingolimod-An Immunomodulating drug

Bindu Gujju Hima*, Annapurna Mukthinuthalapati Mathrusri

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University, Visakhapatnam-530045, India

*Corresponding Author E-mail: bindureddy.frnd@gmail.com

Online published on 20 December, 2018.

Abstract

The authors have proposed a new stability indicating RP-HPLC method for the determination of Fingolimod capsules. Symmetry C18 (150 x 4.6 mm, 5μm particle size) column was used for the chromatographic separation with 0.1% Trifluoro acetic acid: Acetonitrile (50: 50, v/v) mixture as mobile phase. Fingolimod was monitored at 220 nm (UV detector) and the elution was on gradient mode. The flow rate was 1.2 mL/min and the total run time is 10mins. Forced degradation studies were performed to verify the specificity of the method. BeerLambert's law was obeyed over the concentration range 0.5–75 μg/mL with linear regression equation, y = 58537x + 10039 and correlation coefficient 0.9999. The LOD and LOQ are found to be 0.0129 and 0.4061 μg/mL respectively. The proposed method was validated as per ICH guidelines.

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Keywords

Fingolimod, RP-HPLC, Stability Indicating, ICH guidelines.

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