高效液相色谱法测定盐酸米诺环素的含量及有关物质  

Determination and Related Substances of Minocycline Hydrochloride by HPLC

作　　者：高燕霞[1] 刘铁钢[1] 牛长群 

机构地区：[1]河北省药品检验所,石家庄050011 [2]华北制药集团新药研究开发中心,石家庄050015

出　　处：《中国现代应用药学》2006年第1期64-67,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的本文建立了盐酸米诺环素含量及有关物质的HPLC测定方法,并同时考察了全国数批盐酸米诺环素原料的含量及有关物质。方法使用C8柱,以0.2mol/L醋酸铵-N,N二甲基甲酰胺-四氢呋喃(600∶398∶2,内含0.01mol/L乙二胺四乙酸二钠)为流动相,检测波长为280nm。结果盐酸米诺环素的线性范围为0.1 mg/m l^2.0 mg/m l,r为0.9999,盐酸米诺环素的平均加样回收率为100.7%,RSD为0.5%(n=9)。结论方法准确、灵敏度高,本方法可有效地控制药品质量。OBJECTIVE To establish a method for determination of Minocycline Hydrochlofide by HPLC. And we inspected the assay and relative substances of many batches of Minocycline Hydrochlofide in the country. METHODS An C8 column was used. The mobile phase was 0.2 mol/L ammonium acetate -dimethylformamide tetrahydrofuran （ 600：398： 2, including 0.01 mol/L disodium edetate ）, The wavelength of UV detector was 280nm. RESULTS The average recovery of Minocycline Hydrochloride was 100.7% （RSD =0.5%, n =9）. CONCLUSION The method was convenient and accurate. As the same time , the method can intendance and control the related substance in production.

关 键 词：盐酸米诺环素 有关物质 高效液相色谱法 

分 类 号：R512.62[医药卫生—内科学]