异十五烷酸胶囊溶出度测定方法研究

Research on determination of the dissolution of 13-methyl-tetradecanoic acid in 13-methyl-tetradecanoic acid capsules

目的建立异十五烷酸胶囊溶出度测定方法。方法依照《中国药典》（2005年版）附录溶出度项下第二法,以十二烷基硫酸钠为溶出介质,转速为75r·min^-1,高效液相色谱法测定,检测波长：210nm。结果在4.44～22.2μg范围内（r=0.9998）,浓度与峰面积呈良好的线性关系,平均回收率为99.69%,RSD为0.74%（n=9）。结论该方法操作简便,准确可靠。

OBJECTIVE To establish a method for determination of the dissolution of 13-methyl-tetradecanoic acid in 13-methyl-tetradecanoic acid capsules.METHODS Carry out the dissolution test（Pharmacopoeia of the Peoples Republic of China Edition 2005,volume 2,Appendix method 3）,using lauryl sodium sulfate as the solvent,with the rotation speed adjusted to 75r·min^-1.Determination by HPLC,and the detection wavelength was at 210nm.RESULTS There was a good linear relationship within the range of 4.44～22.2μg（r=0.9998）,the average recovery was 99.69%,RSD 0.74%（n=9）.CONCLUSION The method was simple,accurate and precise.