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[摘要]
目的 建立一种测定二母安嗽片中吗啡的方法。方法 采用反相高效液相色谱法测定二母安嗽片中吗啡的量。色谱柱为phenomenex Luna C18(2)(250 mm×4.6 mm,5 μm),流动相为乙腈-0.1%磷酸溶液(15:85)(每100 mL 加0.1 g 庚烷磺酸钠),柱温40 ℃,体积流量1.0 mL/min,检测波长220 nm。结果 吗啡在3.907~97.680 μg/mL 与峰面积积分值呈良好线性关系,平均回收率为96.78%,RSD=0.64%(n=6)。结论 所建立的方法操作简便、测定准确、重复性良好,可用于二母安嗽片的质量控制。
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[Abstract]
Objective To establish a method for the determination of morphine in Ermu Ansou Tablet. Methods RP-HPLC was applied to determine the content of morphine. An RP-HPLC method was established with Luna C18 column (2) (250 mm × 4.6 mm, 5 μm) by a gradient elution using acetonitrile-0.1% phosphoric acid (15:85) (0.1 g sodium heptanesulfonate added into 100 mL); The flow rate was 1.0 mL/min and the wavelength was set at 220 nm. The column temperature was 40 ℃. Results The relationship between injection level and area of morphine was evaluated to be linear at the range of 3.907—97.680 μg/mL. The average recovery rate was 96.78%, and RSD was 0.64% (n = 6). Conclusion The quantitative methods established in this study are convenient, accurate, and reproducible, and can be used as the quality control standard for Ermu Ansou Tablet.
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