KS Rao, KB Deb, MEB Rao, SS Patro, AK Patnaik
A stability-indicating LC assay method was developed for the quantitative determination of Doxazosin mesylate (DXM) in pharmaceutical dosage form in the presence of its degradation products and kinetic determinations were evaluated in acidic and alkaline degradation conditions. Chromatographic separation was achieved by use of LiChroCART-Lichrosphere100 RP-18 column (250 × 4.0 mm, 5 ?¯??m). DXM 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 1.0-300 ?¯??g mL-1 for determination of DXM (r= 0.9992). The acid degradation of DXM in 1M HCl solution showed zero-order kinetics with rate constant 0.45 mole liter-1 minutes-1, while the alkaline degradation with 1M NaOH demonstrated first-order kinetics with rate constant k = 0.0044 min−1. The half-life (t0.5) and shelf life (t0.9) values were also determined for both the kinetic studies. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than critical value. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of DXM in pharmaceutical formulations.
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