坎地沙坦酯氨氯地平片的溶出度测定

目的 建立坎地沙坦酯氨氯地平片中坎地沙坦酯及苯磺酸氨氯地平溶出度测定方法.方法 按照《中国药典》2010年版(二部)附录ⅩC第二法(桨法),转速为50 rpm,以1%吐温20水溶液为溶出介质,45 min时,对坎地沙坦酯取样;以0.01 mol·L-1盐酸溶液为溶出介质,转速为50 rpm,30 min时对氨氯地平取样.采用C18色谱柱,流动相为甲醇-乙腈-20 mmol·L-1癸烷磺酸钠溶液含0.04 mol·L-1磷酸二氢钾(磷酸调 pH 3.5)] (600 :100 :300),检测波长238 nm,流速1.0 mL·min-1.结果 坎地沙坦酯在0.562~8.992 μg·mL-1(r=0.9998)浓度范围内呈良好的线性关系,氨氯地平在0.292~4.672 μg·mL-1(r=0.9995)浓度范围内呈良好的线性关系;坎地沙坦酯、苯磺酸氨氯地平的平均回收率为101.0%±0.8%和100.5%±0.9%.溶出度测定结果限度为坎地沙坦酯45 min大于标示量的75%,苯磺酸氨氯地平30 min大于标示量的80%.结论 所建立的方法专属性好,操作简便,可用于坎地沙坦酯氨氯地平片溶出度的检查.

Dissolution determination of Candesartan Cilexetil andAmlodipine Tablets

Objective To establish a dissolution method of candesartan cilexetil andamlodipine in Candesartan Cilexetil and Amlodipine Tablets.Methods According to the second dissolution method(paddle method)stated in the appendix of Chinese Pharmacopeia(2010 edition),dissolution medium of candesartancilexetil was purified water containing 1% polysorbate 20 and the rotating speed was 50 rpm,after 45 min, the dissolution solution was taken; Dissolution medium of amlodipine was 0.01mol·L^-1 hydrochloric acid solution and the rotating speed was 50 rpm,after 30 min,the dissolution solution was taken.C₁₈ column was used, mobile phase was that methanol- acetonitrile-20 mmol·L^-1 decane sulfonate solution containing 0.04 mol·L^-1 KH₂PO₄ (phosphate tune pH 3.5)] (600:100:300), the detection wavelength was 238 nm and the flow rate was 1.0 mL·min^-1.Results The linear range of candesartan cilexetil was 0.562 ~ 8.992 ug·mL^-1(r=0.9998) and amlodipine was 0.292 ~4.672 ug·mL^-1 (r=0.9995),the average recovery of candesartan cilexetil and amlodipine besylate were 101.0%±0.8% and 100.5%±0.9%,respectively.The dissolution of candesartan cilexetil was above 75% and amlodipine was above 80%.Conclusion The method was convenient and sensitive in the dissolution determination of Candesartan Cilexetil and Amlodipine Tablets.