摘要
目的建立注射用盐酸米诺环素含量及有关物质的HPLC测定方法。方法使用C8柱,以0.2mol/L乙酸铵∶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280nm。结果盐酸米诺环素的线性范围0.1～2.0mg/ml,r=0.9999,注射用盐酸米诺环素的平均加样回收率99.9%,RSD为0.4%(n=9)。结论方法准确可行、灵敏度高,能有效控制产品质量。
Objective To establish a method for content determination of minocycline hydrochloride for injection and its related substance by HPLC. Method A C8 column was used. The mobile phase was 0.2 mol/L ammonium acetate ： dimethylformamide ： tetrahydrofuran （600 ： 398 ： 2, containing 0. 01mol/L EDTA- Na2）. The wavelength for detection was 280nm. Results The standard curve of minocycline hydrochloride was linear （r=0. 9999） in the range from 0. 1-2.0 mg/ml. The average recovery of minocycline hydrochloride for injection was 99.9%, RSD was 0. 4% （n=9）. Conclusion The method is accurate, highly specific and widely applicable and can be used as a method for quality control of minocycline hydrochloride.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2005年第12期744-747,共4页
Chinese Journal of Antibiotics
