布洛伪麻软胶囊含量测定方法的研究

Research on determination of pseudoephedrine hydrochloride and ibuprofen in soft capsules by HPLC

目的 采用高效液相色谱法测定布洛伪麻软胶囊中盐酸伪麻黄碱和布洛芬的含量。方法 采用氰基色谱柱 (4.6mm×2 5 0mm ,填料Kromasil,5 μm) ,以 0 .0 3mol·mL-1三乙胺 (H3 PO4调pH至 6 .5 ) 乙腈 (8∶2 )为流动相 ,流速 1.0mL·min-1,检测波长 2 15nm ,柱温 4 0℃ ,外标法测定。结果 盐酸伪麻黄碱和布洛芬的分离度为 8.72 ;盐酸伪麻黄碱的线性范围为 6 .2 8～2 1.98μg·mL-1,r =0 .9998;平均回收率为 99.89% ,RSD =0 .5 9% ;布洛芬的线性范围为 4 0 .6 4～ 14 2 .2 4 μg·mL-1,r =0 .9999;平均回收率为 10 0 .15 % ,RSD =0 .6 2 % ;二组分精密度分别为 0 .74 %和 0 .75 %结果良好。结论 该法解决了囊壳对软胶囊含量测定的影响 ,可准确检测出软胶囊中主药成分的实际含量。

OBJECTIVE: To determine the contents of pseudoephedrine hydrochloride and ibuprofen in soft capsules by a HPLC method. METHODS: Pseudoephedrine hydrochloride and ibuprofen were separated on a CN column (Kromasil CN, 4.6 mm × 250 mm, 5 μm). The mobile phase was consisted of acetonitrile and 30 mmol&middotmL-1 triethylamine (pH was adjusted to 6.5 6. 5 by H 3PO4) at a flow rate of 1.0 mL&middotmin-1 and the column temperature at 40°C. The detection wavelength was 215 nm. RESULTS: The resolution of pseudoephedrine hydrochloride and ibuprofen was 8.72. The linear calibration curves were obtained over the range of 6.28-21.98 μg&middotmL-1 for pseudoephedrine hydrochloride (r = 0. 999 8) and 40.64-142.24 μg&middotmL-1 for ibuprofen (r = 0. 999 9) respectively. The mean recoveries of the two compounds were (99.89 ± 0.59)% and (100.15 ± 0.62) % respectively with RSD 0.74% and 0.75%. CONCLUSION: The influence of soft capsules shell on the determination was resolved. This method was proved to be suitable for determining the contents of pseudoephedrine hydrochloride and ibuprofen in soft capsules.