用高效液相色谱法测定缓释胶囊中的 5-硝酸异山梨酯

DETERMINATION OF ISOSORBIDE-5-MONONITRATE IN THE CONTROLED RELEASE CAPSULES BY REVERSED- PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

目的建立５－硝酸异山梨酯缓释胶囊高效液相色谱测定法，测定该制剂的含量。为进一步开发此药奠定基础。方法法国Ｇｉｌｓｏｎ高效液相色谱仪；色谱柱ｌｄ为１５０ｍｍ×４．５ｍｍ（ＯＤＳ，５μｍ）；流动相为甲醇－水（１５∶８５）；检测波长２１０ｎｍ。结果工作曲线方程ｈ＝０．２０６１＋０．６４４４ｃ，ｒ＝０．９９９５（ｎ＝７）；回收率１０１．１％；天内天间的相对标准差分别为１．５８％、２．２２％。３个规格（０．０２，０．０４，０．０６ｇ）的标示量百分含量分别为９９．８５％，９９．０９％，１０１．１％。结论本研究所建立的高效液相色谱法具有简便快速、准确度高及重现性好等优点；该缓释胶囊的含量符合规定标准。

オURPOSE To establish high-performance liquid chromatography (HPLC) assay of isosorbide-5-mononitrate in the controled release capsules, so as to lay the ground-work for further devoleping the drug preparation.METHODS HPLC instrument was made by France Gilson. The reversed-phase HPLC system consisted of ODS column (5μm, ld150mm×4.6mm) and methanol-water (15∶85) as mobile phase. Detection wavelength was UV 210nm.RESULTS The regression equation of isosorbide-5-mononitrate with the peak heights h to the concentrations c was h=0.2061+0.6444c, r=0.9995(n=7), rate of recovery was 101.1% and relative standard deviations of within-day and day-to-day were less than 2.3% (n=3). The labelling amount percentages of three specifications (20, 40, 60mg) were respectively 99.85%, 99.09% and 101.1%.CONCLUSIONS This HPLC assay proves to be sensitive, accurate and simple, by which the contents of the preparation can be qualified.