2，4－二硝基氟苯柱前衍生化反相快速HPLC测定核糖霉素

THE KETERMINATION OF RIBOSTAMYCIN BY RAPID RP-HPLC AFTER 1-FLUORO-2, 4-DINITROBENZENE PRE-COLUMN DERIVATIZATION

本文选用２，４－二硝基氟苯（ＤＮＦＢ）柱前衍生化，二极管阵列紫外检测器检测，建立了核糖霉素及杂质新霉胺的反相快速ＨＰＬＣ测定方法。按ＵＳＰ（ＸＸⅡ）版附录分析方法评价的要求，对本方法的重现性、灵敏度、准确度、线性范围等指标作考察，结果满意。因采用高效细颗粒短柱进行分离，整个分析时间于５ｍｉｎ内，实现了高效快速测定。运用所建立的分离测定方法，对硫酸核糖霉素原料药及注射液中核糖霉素及新霉胺的含量分别进行了测定。

In this thesis,a rapid RP-HPLC method has been estab-lished for the analysis of Ribostamycin and impurity Neamine using 1-F1-uoro-2,4-dinitrobenzene (DNFB) pre-column derivatization. A diode array ultraviolet detector has been employed for detection,According to the validation of compendial methods in USP(ⅩⅫ),we have evaluated such performance characteristics as reproducibilily sensitivity,accuracyand linear range etc,The results are satisfied.By using of high-performance short column packed with small pellets(4.6mm×3.3cm, 3μm),the entire analytical time is less than 5 min,The method is efficient and fast,and has been empolyed for the assay of Ribostamycin and impurity Neamine in raw drug and preparation of Ribostamycin sulfate.The column (4.6mm × 3,3cm LD)was Perkin-Elmer RP-C(18), particle size 3 μm,The mobile phase was methanol-acetonitrile-water (6:54:40)with a flow-rate of 1.0 ml/min,The column temperature was 30℃,The detection was carried out at 355nm.