摘要
目的建立高效液相色谱法测定孟鲁司特钠的有关物质。方法色谱柱为Ultimate XB-C18柱（250 mm×4.6 mm,5μm）,流动相为乙腈-体积分数0.1%磷酸溶液（体积比62∶38）,流速为2.0 m L·min-1,检测波长为238 nm。结果孟鲁司特钠及有关物质C质量浓度在0.30～4.2 mg·L-1内,有关物质D/E、F、G质量浓度在0.22～3.1 mg·L-1内,有关物质B质量浓度在0.45～6.3 mg·L-1内与峰面积呈良好的线性关系（r〉0.999）。有关物质B、C、D/E、F及G的平均回收率分别为99.9%、101.4%、100.3%、101.6%和100.2%,RSD分别为1.1%、1.3%、1.4%、0.7%和1.0%（n=9）。结论本方法简便、专属、准确,可用于孟鲁司特钠的有关物质检查。
Objective To establish an HPLC method used for the determination of related substances in montelukast sodium. Methods The analysis was performed on an UltimateXB-C18column（ 250 mm ×4. 6 mm,5 μm） with the mobile phase of acetonitrile- 0. 1% phosphoric acid（ V ∶ V = 62∶ 38）. The flowrate was 2. 0 m L·min- 1,and the detection wavelength was set at 238 nm. Results The calibration curves were linear for montelukast sodium and impurity C in the range of 0. 30- 4. 2 mg·L- 1,for impurity D /E,F and G in the range of 0. 22- 3. 1 mg·L- 1,and for impurity B in the range of 0. 45- 6. 3 mg·L- 1,respectively. The recoveries of the impurity B, C, D / E, F and G were 99. 9%,101. 4%,100. 3%,101. 6% and 100. 2%,with RSDs of 1. 1%,1. 3%,1. 4%,0. 7% and 1. 0%（ n = 9）,respectively.Conclusions The method is simple,specific,accurate and suitable for analyzing the related substances in montelukast sodium.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2015年第9期685-689,共5页
Journal of Shenyang Pharmaceutical University
基金
国家科技支撑计划专项资助项目(2014BAI16B01)
