摘要
目的考察不同厂家的阿立哌唑片剂的有关物质和在不同pH溶出介质中的体外溶出情况。方法采用HPLC法检查有关物质;采用《中国药典》2010年版溶出度第二法进行体外溶出度实验,以HPLC法测定含量,绘制溶出曲线。结果各厂家的阿立哌唑片中均存在两种已知杂质,但杂质含量不同;30 min内在不同溶出介质中的体外溶出度均大于80%。结论不同厂家阿立哌唑片的有关物质和溶出度均符合质量标准,但内在质量有一定差异。
OBJECTIVE To study related impurities and dissolution in vitro in varied pH conditions of Aripiprazole tablets produced in different manufacturers. METHODS HPLC method was adopted to detect related impurities with method 2 in Ch. P 2010, determined by HPLC,and draw real - time dissolution curves. RESULTS There existed two specified impurities in Aripiprazole tablets of all enterprises,and different quantities of impurities were detected. Dissolution was over 80% within 30 min in varied pH conditions. CONCLUSION Aripiprazole tablets produced in different manufacturers satisfy the quality standard,but variation in qualities.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2013年第5期532-534,共3页
West China Journal of Pharmaceutical Sciences
关键词
阿立哌唑
有关物质
溶出度
高效液相色谱法
Aripiprazole
Related impurities
Dissolution
High performance liquid chromatography
