HPLC测定罗红霉素盐酸氨溴索分散片中的两种主药

Determination of two remedium cardinales in Roxithromycin and Ambroxol hydrochloride dispersible tablets by HPLC

目的建立同时测定罗红霉素盐酸氨溴索分散片中罗红霉素和盐酸氨溴索的方法。方法采用HPLC法,色谱柱为Alltech Alltima C18（250 mm×4.6 mm,5μm）;柱温35℃;流动相为5 mmo.lL-1磷酸氢二氨（含5 mmol·L^-1十二烷基硫酸钠和0.5%三乙胺,磷酸调pH5.0）-乙腈（58：42）;流速1.0 ml·min^-1;检测波长210 nm;进样量20μl。结果罗红霉素的线性范围为1.5×10^-3-4.5 mg·ml^-1（r=0.9999）,日内RSD=0.3%,日间RSD为0.9%-1.5%,平均回收率为100.5%;盐酸氨溴索的线性范围为0.06-600μg·ml^-1（r=0.9999）,日内RSD=0.3%,日间RSD为0.9%-1.2%,平均回收率为100.8%（n=6）。结论所建方法简便快速,选择性好,精密度高,可控制罗红霉素盐酸氨溴索分散片的质量。

OBJECTIVE An HPLC method was established for determination of the content of Roxithromycin and Ambroxol hydrochloride dispersible tablets. METHODS The analytical column was Alltech Allfima C18 （250 mm × 4. 6 mm, 5 μm）. The mobile phase was a mixture of 0.05 mol · L^-1 monobasic ammonium phosphate （5 mmol · L^-1 sodium dodecyl sulphate and 0.5% triethyl amine, adjusted pHS. 0 with phosphoric acid） - acetonitrile（58 ： 42）. The flow rate was 1.0 ml·min^-1, the detection wavelength was 210 nm and the injection volume was 20 μl. RESULTS The caliblation curve for roxithromycin was linear in the range from 1.5 μg· ml^-1 to 4.5 mg·ml^-1 （r=0. 9999）. The precision was 0.3%, the repeatability was 0.9% to 1.5% and the average recovery was 100.5%. The calibration curve for Ambroxol hydrochloride was linear in the range from 0. 06 μg·ml^-1 to 600 μg·ml^-1 （r =0. 9999）. The precision was 0.3% , the repeatability was 0.9% to 1.2% and the average recovery was 100. 8%. CONCLUSION The method was simple, selective, accurate and reproducible, and it could be used for the quality control of Roxithromycin and Ambroxol hydrochloride dispersible tablets.