摘要
目的:建立 RP-HPLC 法测定盐酸溴己新片含量及有关物质。方法:采用 RP-HPLC 法,Phenomenex C_(18)柱(150 mm×4.60 mm,5 μm),流动相为乙腈-缓冲液(取磷酸二氢钠3.9 g 和十二烷基硫酸钠2.5 g,加水至1000 mL,摇匀,用磷酸调 pH至2.4)(60:40);流速为1.0 mL·min^(-1),检测波长为248 nm。进样量10 μL。理论板数按盐酸溴己新峰计为5000。盐酸溴己新与相邻有关物质的分离度大于2.0。结果:该方法的线性范围为11.6～104.4 μg·mL^(-1)(r=0.9999),平均回收率为100.1%(n=9),最小检出量为1.5 ng(S/N=3),检出限度为0.01%。结论:该方法测定样品分离效果好,灵敏度高,重现性好,结果准确可靠。
Objective：To establish an HPLC method for the determination of bromhexine hydrochloride tablets and its related substances. Methods： An optimal RP - HPLC was set up. The samples were separated by Phenomenex C18 column （150 mm × 4. 60 mm,5 μm）, with acetonitrile -buffer（ sodium dodecyl sufonate 3. 9 g and sodium lauryl sulfate 2. 5 g were added to 1000 mL water,adjust pH to 2. 4 using phosphoric acid） （60： 40） as mobile phase and detected with UV 248 nm and a flow rate of 1.0 mL · min^-1 Results：The calibration curve was linear in the concentration range of 11.6 - 104. 4 μg · mL^- 1 （ r = 0. 9999 ） for the content determination; The average recovery rate was 100. 1% （n =9）. The detection limit was 1.5 ng. Conclusion ：The method is good in the aspect of separable effect, reproducibility and sensitivity.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第4期508-510,共3页
Chinese Journal of Pharmaceutical Analysis
