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目的建立异海松酸的HPLC测定方法,控制侧柏叶及其制剂侧柏号胶囊和异海松酸胶囊的质量。方法采用高效液相色谱法。色谱条件:KromasilC18柱(200mm×4.6mm,5μm);流动相:甲醇-水-冰醋酸(60∶37∶3);体积流量:1mL/min;柱温:25℃;检测波长:231nm;进样量:10μL。采用外标法计算样品中异海松酸的质量分数。结果异海松酸的线性关系范围为1.25~10.00μg,回归方程为Y=66214X+2487.9,r=1.000。平均回收率为95.8%,RSD为2.7%(n=5)。侧柏叶药材中异海松酸的测定结果分别为3.09、3.20、3.56mg/g,侧柏Ⅴ号胶囊的测定结果分别为10.39、9.67、10.99mg/g,异海松酸胶囊的测定结果分别为553.89、541.50、528.83mg/g。结论该方法简便、准确、分离效果好、无干扰,可用于侧柏及其胶囊的质量评价。
OBJECTIVE To establish a method for the determination of isopimaric acid by HPLC and to control the quality of oriental arborvitae leaf and its preparation orientalis capsule and isopimaric acid capsule. Methods Using high performance liquid chromatography. Chromatographic conditions: Kromasil C18 column (200 mm × 4.6 mm, 5 μm); mobile phase: methanol-water-glacial acetic acid (60:37: 3); volume flow rate: 1 mL / min; Sample size: 10 μL. The external standard method was used to calculate the mass fraction of isopimaric acid in the sample. Results The linear range of isopimaric acid was 1.25-10.00μg, the regression equation was Y = 66214X + 2487.9, r = 1.000. The average recovery was 95.8% with a RSD of 2.7% (n = 5). The results of the determination of isopimaric acid in oriental arborvitae medicinal plants were 3.09, 3.20 and 3.56 mg / g respectively, and the results of oriental arborvitae capsule V were 10.39, 9.67 and 10.99 mg / g, respectively. The determination results of isopimaric acid capsules were 553.89, 541.50, 528.83 mg / g. Conclusion The method is simple, accurate, good separation, non-interference, and can be used for the quality evaluation of oriental arborvitae and its capsule.