HPLC法测定侧柏叶及其制剂侧柏Ⅴ号胶囊和异海松酸胶囊中异海松酸

Determination of isopimaric acid in leaves of Platycladus orientalis and its preparations Cebai No.V Capsula and Isopimaric Acid Capsula by HPLC

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V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：Kromasil C18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 an HPLC method for the determination of isopimaric acid in the leaves of Platycladus orientalis and its preparations Cebai No. V Capsula and Isopimaric Acid Capsula to evaluate the quality of them. Methods HPLC Method was developed. Kromasil C18 （200 mm×4. 6 mm, 5 μm） column was used and the mobile phase, methyl alcohol - water - acetic acid （60 ： 37 ： 3）, float rate ： 1 mL/min, temperature ： 25 ℃, wavelength ： 231 nm, injected volume ： 10 μL. Content of isopimaric acid in samples was calculated by external standard. Results The linearity relationship of isopimaric acid was good in the range of 1.25-10. 00 〉g. The equation of standard curve： Y=66 214 X＋2 487.9, r= 1. 000. The average recovery was 95.8%, RSD= 2.7 % （n = 5）. The determination results of isopimaric acid in three batches of P. orientalis were 3.09, 3.20, and 3.56 mg/g; three batches of Cebai No. V Capsula were 10. 39, 9.67, and 10.99 mg/g; three batches of Isopimaric Acid Capsula were 553.89, 541.50, and 528.83 mg/g. Conclusion The method is reliable, simple, and precise, which could be used for the quality control of P. orientalis and its capsules.