Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING LC METHOD FOR THE ESTIMATION OF FENOFIBRATE

Smita T. Kumbhar*, Amruta B. Loni, Vijay Kothali

Department of Pharmaceutical Chemistry, D.S.T.S. Mandal’s college of Pharmacy, Solapur-413004. Maharashtra, India.

ABSTRACT

A stability-indicating LC assay method was developed for the quantitative determination of Fenofibrate (FFB) in pharmaceutical dosage form in the presence of its degradation products and kinetic determinations were evaluated in acidic, alkaline and peroxide degradation conditions. Chromatographic separation was achieved by use of Zorbax C18 column (250 × 4.0 mm, 5 m). The mobile phase was established by mixing phosphate buffer (pH adjusted 3 with phosphoric acid) and acetonitrile (30: 70, v/v). FFB degraded in acidic, alkaline and hydrogen peroxide conditions, while it was more stable in thermal and photolytic conditions. The described method was linear over a range of 1.0-500 g mL-1 for determination of FFB (r= 0.9999). The precision was demonstrated by relative standard deviation (RSD) of intra-day (RSD= 0.56 – 0.91) and inter-day studies (RSD= 1.47). The mean recovery was found to be 100.01%. The acid and alkaline degradations of FFB in 1M HCl and 1M NaOH solutions showed an apparent zero-order kinetics with rate constants 0.0736 and 0.0698 min−1 respectively and the peroxide degradation with 5% H2O2 demonstrated an apparent first-order kinetics with rate constant k = 0.0202 min−1. The t1/2, t90 values are also determined for all the kinetic studies. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of FFB in pharmaceutical formulations.

Keywords: Fenofibrate, stability-indicating assay, stress degradation study, kinetic degradation.