摘要
建立了测定复方格列美脲片中格列美脲的HPLC并用于自制复方制剂与国外上市制剂的溶出度对比研究。以浓度0.04%的三羟甲基氨基甲烷作为溶出介质,使用D-800LS智能溶出度仪,在228nm波长处测定格列美脲的溶出量。格列美脲浓度在2.544—12.72μg/mL范围内峰面积与浓度呈良好的线性关系,格列美脲的平均回收率为100.3%,相对标准偏差为0.78%。溶出液在8h内稳定。测定结果显示,本品在45min的溶出度可达80%以上。经与国外上市产品比较,自制的复方制剂质量与上市产品一致。
Method for determination of the dissolution of glimepiride in its compound preparations was established and used for the comparative study of dissolution between homemade and foreign listed compound preparation.According to the third act of ChP 2010 edition of two Appendix ⅩC to check the dissolution,0.04% tris was used as a dissolution medium with D-800LS dissolution intelligent instrument and determined the concentration of glimepiride at 228 nm.The results showed that the glimepiride had a good linearity in the range of 2.544—12.72μg/mL（r=0.99993）.The average recovery of glimepiride was 100.3% and the relative standard deviation（RSD） was 0.78%.The sample was stable within 8 hours and the dissolution of glimepiride in 45 minutes was above 85%.Our homemade products are consistency with the listing of products from foreign country.
出处
《光谱实验室》
CAS
2013年第4期1801-1806,共6页
Chinese Journal of Spectroscopy Laboratory
