高效液相色谱法测定孟鲁司特钠散的含量

Determination of the Content of Montelukast Sodium Powder by High Performance Liquid Chromatography(HPLC) Method

目的:用高效液相色谱法对孟鲁司特钠散的含量进行定量检查;方法:ODS柱,以0.025mol/L醋酸铵溶液—乙腈(25:75,按0.02%加入十二烷基硫酸钠,用氨水调p H值为8.0)为流动相,检测波长为270nm,流速1.0ml/min。结果:孟鲁司特钠散在Y=960652X+41179范围内,线性关系良好(R^2=0.9997);精密度试验,RSD=1.39%;平均回收率99.49%,RSD=1.02%;稳定性试验,RSD=0.62%。结论:该方法准确、可靠,重现性好,可用于该药品含量的检测。

Objective：To quantitatively check the content of by high performance liquid chromatography （HPLC） method; Meth- ods： the ODS column to 0.025 mol/L ammonium acetate solution - acetonitrile （captured 5, 0.02% by adding sodium dodecyl sulfate, ammonia adjust pH value of 8.0） as mobile phase, detection wavelength of 270 nm, the flow rate of 1.0 ml/min. Results： Montelukast sodium powder at 960652 x ＋ Y = 41179 range, good linear relationship （R2 = 0.9997）; Precision test, the RSD of 1.39%; The average recovery rate of 99.49%, RSD = 1.02%; Stability test, RSD = 0.62%. Conclusion： the method is accurate, reliable, good reproducibili- ty, can be used for the drug content detection.