HPLC法测定肠胃宁片中补骨脂素和异补骨脂素的含量

Determination of Psoralen and Isopsoralen in Changweining tablets by HPLC

目的建立肠胃宁片中补骨脂素和异补骨脂素的含量测定方法。方法采用高效液相色谱法,色谱柱为Phenomenex ODS柱(4.6×250mm,5μm)分析柱,流动相为甲醇-水(45∶55),检测波长为246nm,流速为1.0mL.min-1,柱温为30℃。结果本法精密度高,稳定性好,补骨脂素进样量在0.109～0.544μg范围内具有良好的线性关系(r=0.9999),平均加样回收率为98.18%,RSD=1.96%(n=9);异补骨脂素进样量在0.102～0.512μg范围内具有良好的线性关系(r=0.9999),平均加样回收率为98.86%,RSD=1.56%(n=9)。结论本方法简便,准确,重现性好,可作为该制剂的含量测定方法。

OBJECTIVE To establish a method for determination of Psoralen and Isopsoralen in Changweining tablets.METHODS Using a HPLC method with Phenomenex ODS （4.6 × 250mm, 5μm） column, the mobile phase consisted of methanol-water（45 ： 55）, the detection wavelength at 246nm, flow rate was 1.0 mL·min^-1, and column temperature was 30℃. RESULTS The precision and stability were fine, the standard curve of Psoralen was rectilinear within the range of 0.109- 0. 544μg, r = 0. 9999. The average rocovery of Psoralen was 98.18 % with RSD of 1.96 %. And the standard curve of Isopsoralen was rectilinear within the range of 0. 102--0. 512μg, r = 0. 9999. The average rocovery of Isopsoralen was 98.86 % with RSD of 1.56 %. CONCLUSION The method was simple, accurate and reproducible, and can be used for the determination of the product.