Development and Validation of Analytical Methods for Quantification and Dissolution of Secnidazole Tablets

Two analytical methods were developed and validated according ICH guidelines to analyze secnidazole tablets. The HPLC method for quantification used: C8 column in 40 degrees C; mobile phase water: acetonitrile (85: 15, v/v); flow 1.0 mL/min; volume of injection 20 mu L; diode array detector at 319 nm; time of analysis 15 min. The method showed specific, linear in the range 0.025-0.150 mg/mL (r(2) = 0.999), precision (RSD < 2%), accuracy (recovery between 100.10-102.39%), and robustness. The UV method to dissolution used: 900 mL of pH 1.2 dissolution medium (simulated gastric fluid) at 37.0 +/- 0.5 degrees C; basket apparatus at stirring speed of 100 rpm. The drug release was evaluated at 276 nm, in 20 min. The method proved to be specific, linear in the range 7.5-22.5 mu g/mL (r(2) = 0.999), precise (% RSD between 2.39-3.30%), and accurate (Recovery between 102.42-103.84%). ANOVA was applied in statistical analysis.