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目的建立安立生坦溶出度、含量及有关物质测定方法,并进行方法学验证。方法含量及有关物质采用Agilent ZORBAX SB-C18色谱柱(4.6 mm×150 mm,5μm);流动相为5 mmol·L-1磷酸二氢钾(p H 2.5)-乙腈(45∶55),柱温:30℃,流速:1.0ml·min-1,检测波长为263 nm;溶出度检测波长:213 nm,其他条件不变。结果含量及有关物质线性回归方程为:A=18 673 C-27.321,r=0.9993(n=7);精密度RSD为0.48%;24 h稳定性RSD为0.78%;平均回收率为100.15%,RSD为1.04%。溶出度线性回归方程:A=75.48 C-5.73,r=0.9993(n=8);精密度RSD为1.12%;稳定性24 h为RSD为1.05%,平均回收率为99.79%,RSD为0.79%。结论本法操作简单、方法准确可靠、专属性好、灵敏度高,可用于安立生坦片的质量研究。
OBJECTIVE To establish the dissolution, content and related substances determination of anritsuram, and to verify the methodology. Methods The content and related substances were determined by Agilent ZORBAX SB-C18 column (4.6 mm × 150 mm, 5 μm). The mobile phase consisted of 5 mmol·L-1 potassium dihydrogen phosphate (p H 2.5) -acetonitrile (45:55) Temperature: 30 ℃, flow rate: 1.0ml · min-1, detection wavelength of 263 nm; dissolution detection wavelength: 213 nm, the other conditions remain unchanged. Results The linear regression equation of contents and related substances was as follows: A = 18 673 C-27.321, r = 0.9993 (n = 7); RSD of precision was 0.48%; RSD of 24 h was 0.78%; average recovery was 100.15% RSD is 1.04%. The linear regression equation of dissolution was A = 75.48 C-5.73, r = 0.9993 (n = 8), the precision RSD was 1.12%, the RSD was 1.05%, the average recovery was 99.79% and the RSD was 0.79% . Conclusion This method is simple, accurate, reliable, specific and sensitive. It can be used to study the quality of Anlisheng Tablet.