World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

VALIDATED RP-HPLC METHOD FOR ESTIMATION OF FINGOLIMOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

N. Naresh*, K. Sujatha and Dr. Arumugam Yasodha

ABSTRACT

A novel, simple, accurate, precise, sensitive and specific analytical RP-HPLC method was developed and validated
for the quantitative estimation of Fingolimod in bulk drugs and pharmaceutical dosage form. Chromatographic
separation was achieved on an Symmetry ODS C18 (4.6×250mm, 5μm) analytical column using mobile phase
composition of methanol and Phosphate Buffer in ratio of (35: 65 v/v) that was set at a flow rate of 1.0μl/min with
detection of 235 nm. The retention time of Fingolimod was found to be 3.006min. The drug was analyzed by
following the guidelines of international conference on Harmonization (ICH). This drug showing linearity in the
concentration range of 6-14μg/ml and the correlation coefficient showing R2 = 0.9996. The % Recoveries showing
within the limits. The presentation of the method was validated according to the present ICH guidelines for
accuracy, precision and robustness, Linearity, limit of quantification, limit of detection linearity.

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