HPLC测定复方盐酸去氧肾上腺素喷鼻液中盐酸去氧肾上腺素、地塞米松磷酸钠和盐酸林可霉素的含量

Determination of the content of phenylephrine hydrochloride,dexamethasone sodium phosphate and lincomycin hydrochloride by HPLC

目的建立一种同时测定复方盐酸去氧肾上腺素喷鼻液中盐酸去氧肾上腺素、地塞米松磷酸钠和盐酸林可霉素含量的HPLC方法。方法采用Agilent C18（150 mm×4.6 mm,5μm）色谱柱,流动相：0.02 mol/L磷酸氢二铵∶乙腈=75∶25（V/V）;柱温30℃,流速1 mL/min,检测波长240 nm,外标法计算含量。结果在该色谱条件下,盐酸去氧肾上腺素、地塞米松磷酸钠和盐酸林可霉素线性良好（r〉0.999,n=5）,加样回收率为97%~103%（n=3）,RSD〈2.0%（n=3）。8 h内可获得稳定的测量结果,测得样品含量合格,为标示量的97%~103%。结论经方法学实验验证,该方法简便、快速,结果准确、可靠、重现性好。

Objective To develop a HPLC method to determine the content of phenylephrine hydrochloride,dexamethasone sodium phosphate and lincomycin hydrochloride in the same time. Methods Phenylephrine hydrochloride,dexamethasone sodium phosphate and lincomycin hydrochloride were separated and determined on a Agilent C18 column（4.6 mm×150 mm,5 μm） with the mobile phase of 0.02 mol/L diammonium hydrogen phosphate∶acetonitrile（V/V 75∶25） and UV-detector at the wavelength of 240 nm. Results Three good linearity were demonstrated by linear equation（r0.999,n=5）.The recovery values were between 97% and 103%（n=3）.The samples were stable in 8 hours and qualified. Conclusions The method was proved to be accurate,sensitive and reliable.