HPLC法测定盐酸二氢埃托啡注射液的含量及有关物质  

HPLC Determination of Content of Dihydroetorphine Hydrochloride Injection and Its Related Substances

作　　者：贾立华[1] 高永良[2] 王世岭[1] 潘强[1] 吴坤[1] 

机构地区：[1]解放军307医院药剂科,北京100039 [2]军事医学科学院毒物药物研究所,北京100850

出　　处：《药物分析杂志》2005年第12期1499-1501,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用高效液相色谱法测定盐酸二氢埃托啡的含量及其有关物质。方法:采用色谱柱为 Diamonsil ODS C_(18)柱(4.6mm×250mm,5μm,迪马公司),流动相为乙腈-0.02mol·L^(-1)KH_2PO_4(23:77),H_3PO_4调 pH 为3.5～4.0,流速为1.0 mL·min^(-1),检测波长为211 nm。结果:HPLC 法测定的线性范围为1.0～50μg·mL^(-1),r=0.9999,最低检测限为1ng,本方法的重复性和精密度良好(RSD<2%)。结论:采用 HPLC 法测定盐酸二氢埃托啡注射剂的含量及有关物质,方法简便,结果准确。Objective ：To establish HPLC method for determination of dihydroetorphine hydrochloride content and its related substances. Methods： Diamonsil ODS C18 column（4.6 mm × 250 mm,5μm） ;The mobile phase ： acetonitrile - 0. 02 mol · L^-1 KH2PO4 （23 ： 77 ）, pH was adjusted to 3.5 - 4. 0 by H3PO4 ; The flow rate was 1.0 mL · min^-1 ;The content of dihydroetorphine hydrochloride injection and its related substances were detected at 211 nm on the same condition. Results： There is a good linear relationship within the range of 1.0 - 50 μg · mL^- 1, r = 0. 9999. The reproducibility and precision of the method are good（ RSD 〈 2% ）. Conclusion：The method proposed for determination of the content and related substances of dihydroetorphine hydrochloride injection by HPLC is simple and accurate.

关 键 词：盐酸二氢埃托啡 含量测定 高效液相色谱法 注射液 有关物质 

分 类 号：R971.1[医药卫生—药品] R927[医药卫生—药学]