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目的建立一种测定温胃舒片中补骨脂素和异补骨脂素含量的反相高效液相法。方法采用Kromasil C18柱,以甲醇-水(55∶45)为流动相,紫外检测波长246 nm,流速1 ml.min-1。结果在所使用的色谱条件下,补骨脂素和异补骨脂素出峰位置未见干扰,补骨脂素和异补骨脂素分别在5.06~30.36μg.ml-1和5.02~30.12μg.ml-1浓度范围内线性关系良好(r=0.9999)。温胃舒片中补骨脂素和异补骨脂素的平均加样回收率分别为97.64%和99.42%,相对标准偏差分别为1.16%(n=6)和0.86%(n=6)。结论该法可信度高,操作简便,重现性好,可用于温胃舒片生产上的质量控制。
Objective To establish a method for determination of psoralen and isopsoralen in Wenweishu Tablets by RP-HPLC. Methods A Kromasil C18 column was used with methanol-water (55:45) as the mobile phase. The UV detection wavelength was 246 nm and the flow rate was 1 ml.min-1. Results Under the chromatographic conditions used, there was no interference in the peak positions of psoralen and isopsoralen. Psoralen and isopsoralen were in the range of 5.06 to 30.36 μg.ml-1 and 5.02 to 30.12, respectively. The linear relationship was good within the μg.ml-1 concentration range (r=0.9999). The average recovery of psoralen and isopsoralen in Wenweishu Tablets were 97.64% and 99.42%, respectively, and the relative standard deviations were 1.16% (n=6) and 0.86% (n=6), respectively. Conclusion The method has high reliability, simple operation and good reproducibility. It can be used for the quality control of Wenweishu Tablet production.