离子对-HPLC法测定盐酸倍他司汀注射液中药物与有关物质含量  

Determination of betahistine hydrochloride and the related substances of betahistine hydrochloride injection by HPLC

作　　者：陆榕[1] 孙进[1] 方金玲[1] 孙英华[1] 刘晓红[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2006年第7期448-451,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的用离子对-HPLC法测定盐酸倍他司汀注射液中药物及有关物质含量。方法色谱柱：Diamonsil C18柱（200mm×4．6mm，5Ⅱm）；流动相：甲醇-10mmol-L11醋酸钠溶液（含5mmol-L11庚烷磺酸钠，体积分数为0．2％的三乙胺，用冰醋酸调pH至3．3）（25：75），检测波长：261nm，流速：1．0mL·min^-1，柱温：室温。结果盐酸倍他司汀质量浓度在1～250mg·L^-1内线性关系良好（r=0．9999），平均回收率为99．8％，RSD=1．0％。盐酸倍他司汀的理论塔板数大于2000，盐酸倍他司汀与其主要杂质分离度不低于1．5。结论适用于盐酸倍他司汀注射液中药物与有关物质的含量测定。Objective To determine betahistine hydrochloride and the related substances of betahistine hydrochloride injection by HPLC. Methods Chromatographic condition included the Diamonsil Cl8 column （200 mm × 4.6 mm, 5 μm ）and mobile phase consisting of methanol-10 mmol·L^-1 sodium acetate solution （including 5 mmol·L^-1 heptanesulfonic sodium, 0.2 % triethylamine, using glacial acetic acid to adjust pH to 3.3）, （25：75）. The detection wavelength was set at 261 nm, the flow rate was 1.0 mL·min^-1, the column temperature was room temperature. Results The linear calibration curves were obtained in the concen- tration range of 1 - 250 mg·L^- 1 （ r = 0. 999 9）. The mean recovery was 99.8 %, RSD = 1.0 %. The theoretical plate number of the betahistine hydrochloride was over 2000, the resolution from its impurities is higher than 1.5. Conclusions This method can be used properly to test the related substances of the product.

关 键 词：盐酸倍他司汀 注射液 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]