HPLC法测定盐酸消旋山莨菪碱注射液的含量及有关物质  

HPLC determination of raceanisodamine hydrochloride injection and its related substances

作　　者：凌霄 徐志洲 

机构地区：[1]山东省药品检验所,济南250101

出　　处：《药物分析杂志》2011年第10期1947-1949,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立盐酸消旋山莨菪碱注射液含量及有关物质的HPLC检测方法。方法:采用C18柱(Intersil,ODS-3,4.6 mm×250 mm,5μm);流动相为0.01 mol.L-1磷酸二氢钾溶液(含0.15%三乙胺,用磷酸调pH至6.5)-甲醇(50∶50),流速1.0mL.min-1,检测波长为220 nm。结果:盐酸消旋山莨菪碱与杂质峰能完全分离,盐酸消旋山莨菪碱在0.1234～0.4112 mg.mL-1浓度范围内线性关系良好(r=0.9999),高、中、低3种不同浓度的回收率为99.2%～99.9%(n=9)。结论:本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。Objective：To establish an HPLC method for the determination of assay and related substances of raceanisodamine hydrochloride injection.Methods：The chromatograph was equipped with a C18 column（Intersil,ODS-3,4.6 mm×250 mm,5 μm）,with mobile phase of a mixture of 0.01 mol·L-1 potassium dihydrogen phosphate solution（with 0.15% triethylamine,adjust pH to 6.5 with phosphoric acid） and methanol（50∶50）,flow rate of 1.0 mL·min-1 and detection wavelength at 220 nm.Results：The data show that this method can clearly separate Raceanisodamine peak from its impurity peaks,with a better linear range of 0.1234-0.4112 mg·mL^-1（r=0.9999）,and average recovery range of 99.2%-99.9% during tests in its high,middle and lower concentrations（n=9）.Conclusion：This method is simple,accurate and reliable,so it can be used for quality control of this preparation.

关 键 词：盐酸消旋山莨菪碱注射液 含量 有关物质 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]