Simultaneous HPTLC and RP‐HPLC methods for determination of bumadizone in the presence of its alkaline‐induced degradation product

Abstract

Accurate, selective, sensitive and precise HPTLC-densitometric and RP-HPLC methods were developed and validated for determination of bumadizone calcium semi-hydrate in the presence of its alkaline-induced degradation product and in pharmaceutical formulation. Method A uses HPTLC-densitometry, depending on separation and quantitation of bumadizone and its alkaline-induced degradation product on TLC silica gel 60 F(254) plates, using hexane-ethyl acetate-glacial acetic acid (8:2:0.2, v/v/v) as a mobile phase followed by densitometric measurement of the bands at 240 nm. Method B comprises RP-HPLC separation of bumadizone and its alkaline-induced degradation product using a mobile phase consisting of methanol-water-acetonitrile (20:30:50, v/v/v) on a Phenomenex C(18) column at a flow-rate of 2 mL/min and UV detection at 235 nm. The proposed methods were successfully applied to the analysis of bumadizone either in bulk powder or in pharmaceutical formulation without interference from other dosage form additives, and the results were statistically compared with the established method.