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目的建立两面针镇痛分散片溶出度的测定方法。方法采用浆法、转速为50 r.min 1,介质900 mL,测定溶出曲线。色谱条件:C18色谱柱,流动相为乙腈-0.02mol.L 1磷酸二氢钾溶液(32∶68),检测波长为328 nm,流速为1 mL.min 1,柱温为30℃,进样量是100μL。结果采用pH 6.8磷酸盐溶液为两面针镇痛分散片的溶出度测定介质时,氯化两面针碱在1.562~18.744μg.mL 1(r=0.999 7)内与峰面积有良好的线性关系。结论本方法简便、准确、专属性强、回收率高,可用于该制剂的质量控制。
OBJECTIVE To establish a method for the determination of elution of analgesic dispersible tablets. Methods Pulp method, the speed of 50 r.min 1, the medium 900 mL, measured dissolution curve. Chromatographic conditions: C18 column, the mobile phase of acetonitrile-0.02mol.L 1 potassium dihydrogen phosphate solution (32:68), detection wavelength of 328 nm, the flow rate of 1 mL.min 1, the column temperature was 30 ℃, injection The amount is 100 μL. Results When pH 6.8 phosphate solution was used as the dissolution medium for analgesic dispersible tablets, the nitidine chloride had a good linear relationship with the peak area in 1.562-18.744μg.mL 1 (r = 0.999 7). Conclusion The method is simple, accurate, specific and high recovery rate, which can be used for the quality control of the preparation.