格列齐特片生物等效性与溶出度评价

Evaluation of Bioequivalency and Dissolution of Gliclazide Tablets

目的 :用HPLC法测定血浆中格列齐特浓度 ,结合溶出度测定评价格列齐特片剂质量。方法 :液相色谱条件为AlltechKromacil-C18柱 ,乙腈 - 0 1mol·L-1磷酸盐缓冲液 (用磷酸调节pH 3 0 ) (5 0∶5 0 )为流动相 ,甲基炔诺酮为内标。UV检测波长 2 2 8nm。结果 :格列齐特在 0 5～ 12 μg·mL-1浓度范围内呈良好线性关系 (r=0 9996 ) ,血浆最低检出量为 0 6ng。测定 3个厂家的格列齐特片的人体内血药浓度和体外溶出度 ,其中有 1个厂的格列齐特片的血药浓度低 ,溶出度与其生物等效性不具相关性。结论

Objective:The bioequivalency and dissolution of three brands of gliclazide tablets were examined in order to evaluate the quality.Methods:The column was Alltech Kromacil-C 18 and the mobile phase was acetonitrile-0 1 mol·L -1 phosphate buffer (pH 3 0,50∶50).Norgestrel was selected as the internal standard.Results:One brand of gliclazide tablet was showing low concentration in human plasma and the dissolution behavior was not correlative to bioequivalency in vivo.Conclusion:Dissolution test must be correlative to the data observed in vivo appropriately.