ISSN: 2249-9504
CAS CODEN: IJPCDX

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Citations : 3566

International Journal of Pharmaceutical, Chemical and Biological Sciences received 3566 citations as per google scholar report

International Journal of Pharmaceutical, Chemical and Biological Sciences peer review process verified at publons

RP-HPLC METHODDEVELOPMENT AND VALIDATIONFOR THE ESTIMATION OF FINGOLIMODINPHARMACEUTICALDOSAGE FORM

Abstract

Author(s): Bodduluri Anil Kumar1*and Pankaj Kumar Sharma2

The purpose of the investigation was to develop a new RP-HPLC method fortheestimationof Fingolimod inpharmaceuticaldosageform. Chromatography wascarriedout onan ODS column(4.6x250mm,particlesize)withaisocratic mobilephase composed of Phosphate buffer and acetonitrile (40:60v/v) ataflowrate of 1.0mL/min. The column temperaturewas maintained at30°C and the detection was carriedoutusingaPDAdetectorat260 nm.Validation parameterssuchas system suitability, linearity,precision,accuracy,specificity, limit of detection, limit of quantification, stabilityof sample and standard stock solutions androbustnesswere studiedas reportedintheInternationalConferenceonHarmonization guidelines. The retentiontimeforFingolimod was2.9min.Therelative standarddeviation for assay oftabletsw a s f o un d t o be less than2%.The methodwasfast,accurate, preciseandsensitivehenceitcanbe employedfor routine quality control ofFingolimodtabletsinquality control laboratories and pharmaceutical industries

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