摘要
目的:建立孟鲁司特钠片溶出度测定方法。方法:采用桨法,以0.2%十二烷基硫酸钠-水为溶出介质,转速为50r·min-1;采用高效液相色谱法测定孟鲁司特钠的浓度并计算溶出度,色谱柱为Ultimate Phenyl,流动相为水-乙腈-三氟乙酸(200∶800∶2),检测波长为389nm。结果:孟鲁司特钠检测浓度线性范围为0.04～0.32mg·mL-1(r=0.9999),低、中、高浓度平均回收率分别为99.39%、99.84%、100.41%(RSD为1.23%、1.51%、0.83%);3批样品在30min时溶出度均在80%以上。结论:本方法准确、可靠,可用于该制剂溶出度的测定。
OBJECTIVE： To establish a method for the dissolution determination of Montelukast sodium tablets. METHODS： The paddle method was adopted with 0.2% sodium lauryl sulfate-water as solvent at rotation speed of 50 r. min^-1. The dissolution rates of montelukast sodium were determined by HPLC with detection wavelength set at 389 nm. Mobile phase consisted of water-acetonitrile-trifluoroacetic acid （200：800：2）. RESULTS： Montelukast sodium showed a good linear relationship within the range of 0.04-0.32 mg.mL^-1 （r=0.999 9）; the average recovery rates of low, medium and high concentrations of montelukast sodium were 99.39%, 99.84% and 100.41% （RSD=l.23%, 1.51% ,0.83%）; the dissolution rate of 3 batches of samples were all above 80 % at 30 min. CONCLUSION： The method is accurate, reliable and applicable for the dissolution determination of Moutelukast sodium tablet.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第13期1213-1215,共3页
China Pharmacy
关键词
孟鲁司特片
溶出度
桨法
高效液相色谱法
Montelukast sodium tablet
Dissolution rate
Paddle method
HPLC
