HPLC法测定麦角隐亭咖啡因片的溶出度和含量均匀度

目的:建立一种比比色法更简便、准确的方法(HPLC法)来测定洛斯宝片的溶出度和含量均匀度.方法:采用反相高效液相色谱法,用外标法测定洛斯宝片的溶出度和含量均匀度.用十八烷基硅烷键合硅胶为填充剂,以磷酸二氢铵-乙腈(用磷酸调节pH 2.0)=70:30为流动相,流速1.2 mL·min-1,于290 nm波长处检测,按外标法以峰面积计算其含量及每片的溶出量.结果溶出度的线性回归方程为:y=6 152x-2 743.7,r=0.999 9(n=5),平均回收率为100.6%,RSD为0.6%(n=9);含量均匀度的线性回归方程为:y=7 285.2x-334.65,r=1(n=5),平均回收率为98.5%,RSD为0.4%(n=9).结论:实验证明该法简便快捷,能准确地测定产品的溶出度和含量均匀度.

Determination of the Dissolution and Uniformity of dosage of Vasobral Tablets by HPLC

Objective: To establish a more simple and accurate method(HPLC)to determine the dissolution and uniformity of Vasobral Tablets.Method: C₁₈ column was used,with acetonitrile -0.01 mol·L^-1 of ammonium dihydrogen phosphate(adjusted the solution with phosphoric acid to pH 2.0)as mobile phase;the flow rate was 1.2mL/min and the detection wavelength was 290 nm.The dissolution and concentration was quantified external standard.Results: The regression equation for dissolution of Vasobral was y=6 152x-2 743.7,r=0.999 9(n=5)and the average recovery rate of the sample was 100.6%(RSD=0.6%,n=9);the regression equation for uniformity of dosage of Vasobral was y=7 285.2x-334.65,r=1(n=5)and the average recovery rate of the sample was 98.5%(RSD=0.4%,n=9).Conclusion: This method is convenient,quick and reproducible for the quantitative determination of Vasobral in the dissolution and uniformity of dosage.