摘要
目的用当前和放置六年后的盐酸多西环素样品验证HPLC法适合于测定盐酸多西环素中的有关物质。方法色谱柱:Hamilton柱(250×4.6mm,7um)(苯乙烯-二苯乙烯填料),柱温:60℃,流动相:叔丁醇-硫酸四丁基氢铵-EDTA(15∶125∶1),检测波长:254nm。结果及结论本法专一性好,最小检测限,分离度,耐用性均符合规定。适合于盐酸多西环素的稳定性试验中有关物质的检测。
OBJECTIVE To establish a HPLC method for determination of related substances in Doxycycline Hyclate, Samples of both current production and batches which laid aside for 6 years. METHODS Column： Hamilton （250 × 4.6mm, 7μm） column packed with styrene- divinylbenzene copolymer, column temperature： 60℃, UV detection wavelength： 254nm. Mobile phase： Tert-butyl alcohol-Tetra-n-butylammonium hydrogen sulfate-EDTA（15：125：1）. RESULTS and CONCLU- SION This method was specificity, the minimal examination limits, degree of dissociation and durability conformed to the stipulation, It was suitable for detecting related substances of doxcycline hyclate in stability tests.
出处
《齐鲁药事》
2006年第3期159-160,共2页
qilu pharmaceutical affairs
