莫达非尼肠溶片质量标准研究

目的 建立莫达非尼肠溶片的质量标准.方法 采用反相高效液相色谱法测定莫达非尼肠溶片的含量、释放度及其有关物质.结果 该方法具有良好的线性相关性、精密度、稳定性和回收率.莫达非尼肠溶片平均含量为99.6%;在盐酸溶液中2 h无崩解或裂片,在磷酸盐缓冲液45 min的释放度大于75%,且批间重视性良好;有关物质浓度均小于莫达非尼浓度的1%.结论 反相高效液相色谱法可用于莫达非尼肠溶片制剂的质量控制,莫达非尼肠溶片质量标准切实可行.

Study on Quality Criteria of Modafinil Enteric-Coated Tablet

Objective To establish the quality criteria of modafinil enteric-coated tablet（MET）.Methods The RP-HPLC method was adopted to determine the content,release degree and related substance of MET.Results The method had good linear correlation,precision,stability and recovery.The mean content of modafinil was 99.6%.MET did not splinter or disintegrate after 2 h in HCl solution.The release degree exceeded 75%and had a favorable reproducibility among different batches for 45 min in phosphoric acid buffer solution.The concentration of related substances was less than 1%of the modafinil concentration.Conclusion The RP-HPLC method can be used to control the quality of MET,and its quality criteria is realistic and feasible.