Sai Pavan Kumar B, Mathrusri Annapurna M, Pavani S
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam 530045, India.
J Pharm Anal. 2013 Feb;3(1):66-70. doi: 10.1016/j.jpha.2012.08.003. Epub 2012 Sep 5.
A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of water-acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was observed over the concentration range 1.0-200 μg/mL (=0.9997) with regression equation =113190 +63053. Rufinamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Rufinamide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
建立了一种稳定性指示反相高效液相色谱法，并对其进行了验证，用于测定片剂剂型中的鲁非酰胺。采用C18柱（250mm×4.6mm，5μm），流动相为水-乙腈（40:60，v/v），流速为0.8mL/min（紫外检测波长215nm）。在1.0-200μg/mL的浓度范围内观察到线性关系（=0.9997），回归方程为=113190 +63053。鲁非酰胺经受了酸性、碱性、氧化、光解和热降解等强制降解条件。鲁非酰胺对酸性降解更敏感。该方法按照国际人用药品注册技术协调会（ICH）指南进行了验证。
