高效液相色谱法测定复方替加氟胶囊含量及其溶出度

 目的建立一种高效液相色谱法测定复方替加氟胶囊含量及其溶出度。方法采用Diamonsil-C₁₈柱(5μm，4.6 mm×250 mm)，用冰醋酸调节甲醇-2 mmol·L^-1庚烷磺酸钠溶液(10∶90)pH值至3.50，抽滤后，每1000 mL溶液加乙醚2mL为流动相，流速为1.0 mL·min^-1，UV检测波长为280 nm。结果此方法线性关系良好，替加氟与尿嘧啶的平均回收率为100.0%，100.7%，RSD为0.21%，0.98%(n=9)。结论本方法简单、快速、结果准确可靠，为控制复方替加氟胶囊的质量提供了依据。

Studies on dissolution of compound tegafur capsules by means of HPLC assay

OBJECTIVE A HPLC method was established for the determination of tegafur and uracil in compound tegafur capsules and its dissolution. METHODS The chromatographic condition was as following: Diamonsil C₁₈column (5μm,4.6 mm×250mm);methanol and 2 mmol·L^-1sodium sulphonate heptane solution (10∶90,adjusted pH to 3.50 by acetic acid),with 2 mL diethyl ether to 1000 mL solution as the mobile phase.The flow rate was 1.0 mL·min^-1.The wavelength of detection was 280 nm. RESULTS The mean recoveries of tegafur and uracil were 100.0% and 100.7% with RSD 0.21% and 0.98%(n=9) respectively. CONCLUSION The proposed method appeared bo be simple,rapid,accurate and reliable.