HPLC同时测定复方布洛芬软胶囊中布洛芬、对乙酰氨基酚的含量

 目的采用高效液相色谱法同时测定复方布洛芬软胶囊中布洛芬和对乙酰氨基酚的含量。方法采用氰基色谱柱,以磷酸盐缓冲液(pH6.6)-甲醇(60:40)为流动相,流速为1.0 mL·min^-1,检测波长为223nm,柱温30℃,外标法测定。结果布洛芬和对乙酰氨基酚与已知杂质时氨基酚、对氯苯乙酰胺之间能够达到很好分离,理论板数以对乙酰氨基酚峰计为12 696,以布洛芬峰计为4 188;布洛芬的线性范围为0.21～124.86μg·mL^-1,r=0.999 9(n=9),平均回收率为99.80%,RSD=0.26%;对乙酰氨基酚的线性范围为0.17～100.14μg·mL^-1,r=0.999 9(n=9),平均回收率为99.82%,RSD=0.28%;两组分精密度分别为0.31%和0.36%,结果良好。结论该法能够同时准确测定两组分的含量,而且简便、准确、快速,可用于批次样品的含量测定及质量控制。

Determination of ibuprofen and paracetamol in soft capsules by HPLC

OBJECTIVE To establish a HPLC method for the detennination of ibuprofen and paracetamol in soft capsules.METHODS Ibuprofen and paracetamol were separated on a CN column. The mobile phase consisted of methanol and phosphate buffer( pH 6.6) (60:40) at a flow rate of 1.0 mL·min^-1 the column temperature was at 30℃. The detection wavelength was 223 nm.RESULTS The resolution of p-aminophenol, paracetamol, ibuprofen and p-chloroacetanihde were good. The theroretical plate number of ibuprofen and paracetamol were 4 188 and 12 696, respectively.The linear calibration curves were obtained over the range of 0.21～124.86 μg·mL^-1 for ibuprofen (r=0.999 9, n =9) and 0.17～100.14 μg·mL^-1 for paracetamol (r=0.999 9,n=9), respectively. The mean recoveries of the two compounds were (99.80 ±0.26)% and (99.82±0.28) % with RSD0.31% and 0.36%, respectively.CONCLUSION This method was simple,rapid,accurate,and suitable for quality control of samples.