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高效液相色谱法测定扎莱普隆胶囊的含量
Quantitation of zaleplon capsules by HPLC
【摘要】 目的:建立测定扎莱普隆胶囊的高效液相色谱法。方法:采用C18色谱柱(150 mm×3.9 mm,5μm),流动相为甲醇-0.02 mol·L-1醋酸铵水溶液(pH 5.00)(60:40),流速0.8 mL·min-1,检测波长232 nm,选用阿普唑仑为内标物。结果:在扎莱普隆浓度为1~100μg·mL-1范围内,扎莱普隆色谱峰面积与内标阿普唑仑色谱峰面积的比值(R)和扎莱普隆浓度(C)呈良好的线性关系,线性方程为:R=2.83×10-2C+4.58×10-2,r=0.999 9,(n=7),扎莱普隆样品与内标物的色谱峰分离完全,两者分离度R>1.5,高、中、低3种浓度的平均加样回收率为98.83%~100.5%,日内精密度(RSD)<0.83%,日间精密度(RSD)<1.6%。结论:该方法灵敏、快速、操作简便、测定结果准确可靠。
【Abstract】 Objective: To develop a HPLC method to quantify zaleplon capsules. Methods:The quantitation was carried out by HPLC (Waters symmetry shieldTM) consisted of a RP18 column (150 mm×3.9 mm, 5μm) , a mobile phase of methanol-0. 02 mol·L-1 ammonium acetate buffer (60:40) with a flow rate of 0. 8 mL·min-1 and a detection wavelength at 232 nm. Alprazolam was used as internal standard. Results:A linearity of zaleplon concentration was in the range of 1~100μg·mL-1 (r =0.999 9, n = 7). The average recovery was 98. 83%~100. 5% , the within-day RSI) was lower than 0. 83% and among-day RSD was lower than 1.6%. Conclusion:The simple and reliable HPLC method is attainable.
【Key words】 zaleplon; alprazolam; high performance liquid chromatography;
- 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2006年15期
- 【分类号】R927
- 【下载频次】42