RP-HPLC法测定盐酸帕罗西汀片的含量

Determination of proxetine hydrochloride tablets by RP-HPLC

目的 :建立测定盐酸帕罗西汀片中盐酸帕罗西汀含量的反相高效液相色谱法。方法 :采用 CL S- ODS柱 (15 0 mm× 6 .0mm I.D) ,甲醇 - p H 4.5 0 .0 5 m ol/ L醋酸钠缓冲液 (6 5∶ 35 )为流动相 ,用紫外检测器于 2 95 nm波长处检测。结果 :平均回收率为 10 0 .5 % ,RSD为 0 .82 % ,n=5。线性范围为 0 .10～ 0 .5 0 m g/ m L (r=0 .9999)。结论 :本法具有简便、快速、准确、可靠等优点 。

Objective:To establish a RP HPLC method for the determination of proxetine hydrochloride in its tablets.Methods:Proxetine hydrochloride can be separated on CLC ODS column with a mixture of methonal and pH 4.5 0.05 mol/L sodium acetate buffer (65∶35) as mobile phase and detected at 295 nm.The flow rate was 1.5 mL/min.Results:The standard curve was linear between 0.10 mg/mL and 0.50 mg/mL and the correlation coefficient was 0.9999 .The average recovery and relative standard deviation were 100.5% and 0.82% respectively.Conclusion:The method for the determination of proxetine hydrochloride in its pharmaceutical substances and tablets is simple,rapid,accurate and reliable.