VALIDATED STABILITY- INDICATING HPLC METHOD FOR DETERMINATION OF RAFOXANIDE IN PURE FORM AND PHARMACEUTICAL FORMULATION
Mohammad Wafaa I. Nassar, Khalid Abdel-Salam M. Attia, Ahmed Abdelhalim A. Mohamad,
Ragab Ahmad M. Said and Rady Fathy A. Gaber*
ABSTRACT
A simple, sensitive and accurate stability-indicating HPLC method was developed and validated for the determination of rafoxanide in presence of its degradation products. Analysis was carried out on an BDS Hypersil C18 column (250mm, 4.6mm, 5μm particle size) using a mobile phase consists of acetonitrile: 0.1M ammonium acetate (70:30, v/v). The analysis was performed at ambient temperature with a flow rate of 1 mL/min and UV detection at 240 nm. Drug was exposed to different forced degradation conditions like hydrolysis, oxidation, thermal and photolysis. The method has been linear for the range of 10 – 70 μg/mL with r2 0.9996. This work focused on the stability of rafoxanide and its degradation behaviour under different stress conditions. The method was validated according to the ICH guidelines and successfully applied to the determination of the drug in pure form and in its pharmaceutical preparation without interference from its degradation products.
Keywords: Degradation products, HPLC, rafoxanide, stability indicating.
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