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Abstract

COMPARATIVE STABILITY INDICATING ASSAY METHOD OF DEFERASIROX BY RP-HPLC AND HPTLC

Neha A. Bhatt and *Prof. Dr. Dhrubo Jyoti Sen

ABSTRACT

Two methods have been developed for estimation of Deferasirox in Dispersible tablet dosage form. In RP-HPLC method, chromatographic separation was achieved on Kromasil, C18 (250×4.6mm, 5μm) column using Methanol: 0.1% Formic acid (80:20) as the mobile phase with UV detection at 248nm. The drug was subjected to acidic, alkali, oxidative, thermal and photolytic stress conditions; whereas, tablet was subjected to thermal and photolytic stress conditions. In HPTLC method, chromatographic separation was carried out on TLC plate, precoated with silica gel 60F248 using mobile phase Methanol:n-Butyl Acetate (3.5:6.5) and scanning at 248nm. RP-HPLC method showed adequate linearity 2-10μg/mL for DEFE. The mean recoveries for both the methods were found in between for RP-HPLC 99.91–102.1% and HPTLC 98%-102% for both the drugs. The method successfully separates the Deferasirox from their degradation products formed under stressed conditions. Deferasirox was marginally degraded in acidic and oxidative conditions slightly degraded in alkaline condition and was found to be stable in all other conditions. HPTLC methods showed satisfactory linearity with correlation coefficient greater than 0.99 and linearity was demonstrated from 500- 3000ng/band for DEFE. The method successfully separates the Deferasirox from their degradation products formed under stressed condition.

Keywords: Deferasirox, Validation, As per ICH guideline Q2(R1), Degradation, RP--HPLC, HPTLC.


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