摘要
目的:建立布洛芬颗粒的有关物质检测的高效液相色谱法。方法:采用ODS柱(150mm×4.6mm,5μm),梯度洗脱的HPLC法进行分离,流速为2ml·min^(-1),检测波长为214nm。结果:在调整后的流动相体系下,布洛芬峰与相邻杂质峰达到有效分离,样品溶液室温放置10h,峰面积RSD为0.07%,溶液稳定性较好。结论:该方法准确、可靠,重复性好,可用于该药品的质量控制。
Objective ： To propose an HPLC method for the determination of relevant substances in ibuprofen granules. Method ： A SHIMADZU VP-ODS column （ 150 mm ×4.6mm,5μm） was used with gradient elution. The flow rate was 2ml · min-1. The detec- tion wavelength was 214nm. Result： Ibuprofen and the adjacent impurities achieved effective separation. The sample solution was sta- ble in 10 h at the room temperature, and RSD was 0.07%. Conclusion： The method is accurate,reliable and reproducible, and can be used in the quality control of the preparation.
出处
《中国药师》
CAS
2013年第10期1534-1536,共3页
China Pharmacist
