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目的:建立同时测定复方罗红霉素片中盐酸氨溴索和罗红霉素的含量及有关物质的HPLC法。方法:采用Apollo C18柱(150 mm×4.6 mm,5μm);以0.045 mol.L-1磷酸二氢铵溶液-乙腈(2∶1)(用三乙胺调pH值至7.35)为流动相A,乙腈为流动相B进行梯度洗脱;检测波长为210 nm;流速为1.0 mL.min-1;柱温为40℃。结果:盐酸氨溴索和罗红霉素的线性范围分别为为1~6μg.mL-1(r=0.999 9,n=5)和5.1~30.6μg.mL-1(r=0.999 8,n=5)回收率分别为100.1%和99.8%(n=9)。结论:本方法快速、简便、分离效果好,可用于复方罗红霉素片的质量控制。
Objective: To establish an HPLC method for simultaneous determination of ambroxol hydrochloride and roxithromycin in compound roxithromycin tablets and related substances. METHODS: Apollo C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase A was 0.045 mol·L -1 ammonium dihydrogen phosphate solution - acetonitrile (2:1), adjusted to pH 7.35 with triethylamine , Acetonitrile as mobile phase B gradient elution; detection wavelength of 210 nm; flow rate of 1.0 mL.min-1; column temperature was 40 ℃. Results: The linear ranges of ambroxol and roxithromycin were 1 ~ 6μg.mL-1 (r = 0.999 9, n = 5) and 5.1 ~ 30.6μg.mL- = 5) The recoveries were 100.1% and 99.8%, respectively (n = 9). Conclusion: The method is rapid, simple and effective in separation and can be used for the quality control of compound roxithromycin tablets.