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,5μm）,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3.907~97.680μg/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。
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,5μm） 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.
出处
《药物评价研究》
CAS
2014年第5期434-436,共3页
Drug Evaluation Research
