高效液相色谱法测定盐酸川芎嗪氯化钠注射液的含量及有关物质  

Determination of Ligustrazine Hydrochloride and Drug-Related Impurities in Ligustrazine Hydrochloride and Sodium Chloride Injection by HPLC

作　　者：夏赛忠[1] 

机构地区：[1]浙江省嵊泗县人民医院,浙江舟山202450

出　　处：《中国药业》2010年第7期34-35,共2页China Pharmaceuticals

摘　　要：目的建立测定盐酸川芎嗪氯化钠注射液中盐酸川芎嗪含量及其有关物质检查的高效液相色谱法。方法色谱柱为Hypersil C18柱(250mm×4.6mm,10μm),以乙腈-水(40∶60)为流动相,检测波长为295nm,流速为1.0mL/min,柱温为30℃。结果盐酸川芎嗪质量浓度在2.5～40.0μg/mL范围内与峰面积线性关系良好(r=0.9999),高、中、低3种量级的平均加样回收率为99.6%～100.3%,RSD为0.54%-0.82%,有关物质检查的限量为1.0%。结论该法准确、简便、快速,适用于盐酸川芎嗪氯化钠注射液的质量控制。Objective To establish a HPLC method for the determination of ligustrazine hydrochloride and the drugrelated impurities in Ligustrazine Hydrochloride and Sodium Chloride Injection. Methods The Hypersil C18 column（250 mm ×4. 6 mm, 10μm） with UV detection at 295 nm, and the mobile phase consisted of acetonitrile and water（40：60） were used. The flow rate was 1.0 mL/min. The column temperature was 30 ℃. Results The calibration curve was linear（ r = 0. 999 9） within the range of 2.5- 40.0 μg/mL for ligustrazine hydrochloride, the average recovery rate was from 99.6% to 100.3% for three different levels of the amount of ligustrazine hydrochloride, RSD was from 0. 54% to 0. 82%, And the limit for drugrelated impurities was 1.0%. Conclusion This method is simple, quick, accurate and effective for testing the related compounds in Ligustrazine Hydrochloride Injection and its content determination. It is suitable for the quality control for Ligustrazine Hydrochloride Injection.

关 键 词：川芎嗪 含量测定 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R972