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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。
A HPLC method was developed for the determination of glimepiride in compound glipizide tablets. Dissolution of glimepiride was measured at a wavelength of 228 nm using a D-800LS Smart Dissolution Apparatus at a concentration of 0.04% Tris as dissolution medium. The peak area of glimepiride in the range of 2.544-12.72μg / mL showed a good linear relationship with the concentration. The average recoveries of glimepiride were 100.3% and the relative standard deviations were 0.78%. Dissolution in 8h stable. Measurement results show that the dissolution of this product in 45min up to 80%. Compared with the products listed in foreign countries, the quality of homemade preparations is the same as that of listed products.