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。
Objective： To develop a HPLC method to quantify zaleplon capsules. Methods： The quantitation was carried out by HPLC （Waters symmetry shield^TM） 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 RSD was lower than 0. 83% and among-day RSD was lower than 1.6%. Conclusion ： The simple and reliable HPLC method is attainable.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2006年第15期1276-1278,共3页
Chinese Journal of New Drugs
关键词
扎莱普隆
阿普唑仑
高效液相色谱法
zaleplon
alprazolam
high performance liquid chromatography
