高效液相色谱法测定盐酸文拉法辛缓释片的主药含量

目的:建立测定盐酸文拉法辛缓释片中盐酸文拉法辛含量的方法。方法:采用高效液相色谱法,色谱柱为Phenomenex C18(250 mm×4.6 mm,5μm),流动相为乙腈-甲醇-0.02 mol.mL-1磷酸二氢钠溶液(用10%磷酸调节pH值至3.0)(V∶V∶V=25∶15∶60),柱温为35℃,流速为1.0 mL.min-1,检测波长为226 nm。结果:盐酸文拉法辛进样量在0.604 8～3.024μg范围内与峰面积积分值呈良好的线性关系(r=0.999 0,n=5),平均加样回收率为97.51%,RSD=0.75%(n=9)。结论:本方法简便、准确度高、重现性好、可操作性强,可用于盐酸文拉法辛缓释片中盐酸文拉法辛的含量测定。

Determination of Venlafaxine Hydrochloride in Venlafaxine Hydrochloride Sustained-Release Tablets by HPLC

OBJECTIVE: To establish a method for determining the content of venlafaxine hydrochloride in venlaxine hydrochloride sustained-release tablets.METHODS: HPLC method was applied using phenomenex C18 chromatographic column(4.6 mm× 250 mm,5 μm).The mobile phase consisted of acetonitrile-methanol-0.02 mol ·mL-1 sodium dihydrogen phosphate(V∶V∶V = 25∶15∶60)(adjusting pH=3.0 by phosphoric acid) at flow rate of 1.0 mL·min-1.The column temperature was set at 35 ℃ and detection wavelength was set at 226 nm,RESULTS: The linear range of venlafaxine hydrochloride was 0.604 8-3.024 μg(r=0.999 0,n=5) with an average recovery of 97.51%(RSD=0.75%,n=9).CONCLUSION: The method is simple,accurate,reproducible and operable,and it is applicable for the determination of venlafaxine hydrochloride in venlaxine hydrochloride sustained-release tablets.