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

作者：Pinto Marcia F^*; Moura Elisana A; Santos Ana F O; Correia Lidiane P; Procopio Jose V V; Macedo Rui O

来源：Latin American Journal of Pharmacy, 2014, 33(4): 613-623.

• Dissolution
• HPLC
• Quantitation
• Secnidazole
• UV
• Validation

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 %26lt; 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.

• 出版日期2014