HPLC法测定肺宝三效片中苯妥英钠的含量和体外溶出度

Determination of content and dissolution of dilantin in Feibaosanxiao tablets by HPLC

目的 建立测定肺宝三效片中主药苯妥英钠的含量和体外溶出度的高效液相色谱方法 ,以控制产品质量。方法 采用SinochromC1 8柱 ,以甲醇 -水 (5 7∶4 3,V V)为流动相 ,检测波长为 2 15nm ,流速为 1ml min,用苯巴比妥钠作内标物 ,以内标法定量 ;采用水为溶出介质 ,转速 10 0r min。结果 本法测定线性范围为 0 .0 0 6 0～ 0 .4 0 0 8mg L ,r =0 .9997,平均回收率为 99.6 % ,RSD为 1.3% ,苯妥英钠在 4 5min可溶出 6 0 %。结论 本法具有简便、快速、结果可靠等特点 ,可用于该制剂的质量控制。

Objective To establish a HPLC method for determining the dissolubility of Feibaosanxiao tablets. Methods An RP-C 18 was used as the stationary phase and a solution composed of methanol∶ water (57∶ 43, V/V) as the mobile phase with a flow rate of 1 ml/min. The detective length was 215 nm. Water was used as the medium of dissolubility with the rotative rate of 100 r/min. Results The standard curve was linear within the range of 0.006 0～0.400 8 mg/L.The mean recovery and RSD were 99.6%,1.3%, and 60% of dilantin can be dissolubed in 45 min. Conclusion This method is simple, accurate and useful in quality control of Feibaosanxiao tablets.