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目的采用HPLC法测定盐酸安非他酮片的含量。方法色谱柱为迪马C8柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(含0.007 mol.L-1庚烷磺酸钠、0.01 mol.L-1三乙胺、0.05 mol.L-1磷酸二氢钾)-乙腈(60:40,磷酸调pH3.2),检测波长为251 nm。结果盐酸安非他酮在0.8~4.0μg与峰面积呈良好的线性关系(r=0.9992),平均回收率为99.6%,RSD=0.17%。结论所建方法准确可靠,专属性强,可为修订该制剂的质量标准提供参考。
Objective To determine the content of bupropion hydrochloride tablets by HPLC. METHODS The mobile phase consisted of Dima C8 column (250 mm × 4.6 mm, 5 μm) with phosphate buffer (containing 0.007 mol·L -1 heptane sulfonate, 0.01 mol·L -1 triethylamine, 0.05 mol.L-1 potassium dihydrogenphosphate) -acetonitrile (60:40, pH adjusted to 3.2 with phosphoric acid) at a detection wavelength of 251 nm. Results Bupropion hydrochloride showed a good linear relationship (r = 0.9992) with the peak area of 0.8 ~ 4.0μg. The average recovery was 99.6%. The average RSD was 0.17%. Conclusion The established method is accurate and specific, and can provide a reference for revising the quality standard of the preparation.