右美沙芬愈创甘油醚糖浆质量研究

Dextromethorphan guaifenesin syrup quality research

建立了测定右美沙芬愈创甘油醚糖浆中氢溴酸右美沙芬和愈创木酚甘油醚含量的HPLC方法。采用C18柱,以2%磷酸-乙腈为流动相,以280 nm为检测波长,流速为1.0 mL/min。结果表明,氢溴酸右美沙芬和愈创木酚甘油醚分离度为7,线性范围分别是50～250μg/mL(RSD=99.98%)和333.6～1 668μg/mL(RSD=99.99%);精密度RSD分别是0.29%和0.24%(n=6);重复性RSD分别是0.14%和0.12%(n=6);平均回收率为100.53%和100.62%,RSD分别为1.32%和0.41%(n=9)。本法准确可靠,简便快捷,可用于市售右美沙芬愈创甘油醚糖浆的质量监控。

To establish HPLC method for the determination of Dextromethorphan hydrobromide and guaifenesin at the same time. C18 Column was used ,with a mobile phase of 2% phosphoric acid-acetonitrile ,the detective wavelength was at 280 nm, the flow rate was 1.0 mL/min. The results showed that the degree of separation Dextromethorphan hydrobromide and guaifenesin was 7. The calibration curves for Dextromethorphan hydrobromide and guaifenesin were linear over the range of 50 - 250 μg/mL （RSD = 99.98% ） and 333.6 - 1 668μg/mL（ RSD = 99.99% ） , respectively. The RSD of precision was 0.29% 和 0.24% （ n = 6） ; the RSD of repeatability was 0.14% 和 0.12% （ n = 6） ; the average recovery rate was 100.53% （ RSD = 1.32% ） and 100.62% （ RSD = 0.41% ） （ n = 9） respectively. This method is speed accuracy and reliability, can be used for quality control of Dextromethorphan guaiae glycerin ether syrup.