摘要
目的:研究复方当归川芎注射液特征峰的特定(指纹)图谱,为科学评价及有效控制其质量提供可靠方法。方法:利用RP-HPLC 梯度洗脱方法进行复方当归川芎注射液特定(指纹)图谱分析,建立了10批注射液的特定(指纹)图谱。结果:特定(指纹)图谱方法学考察中精密度、重复性 RSD 均小于3%,样品溶液12h 内稳定,10批注射剂得到的色谱特定(指纹)图谱有17个共有峰,其中峰面积百分比大于5%的共有峰有5个,以藁本内酯峰(即16号峰)作为参照峰,10批注射剂中各共有峰相对保留时间的 RSD 小于2.6%,峰面积大于5%的共有峰相对峰面积的 RSD 小于1.5%。结论:复方当归川芎注射液的特定(指纹)图谱特征性及专属性强,可结合含量测定用于全面控制注射液的质量,确保每一批制剂的均一性。
Objective： To establish a sensitive and specific HPLC method for controlling the quality of the composite injection of Radix Angelicae Sinensis and Rhizoma Chuanxiong. Methods： RP - HPLC gradient programs were applied for quality assessment of the injection, and the specific （fingerprint） chromatogram of the injections from 10 batches was established. Results：RSD of precision and reproduction of the method were less than 3%, and the sample was stable within 12 h. The HPLC chromatographic specific fingerprints of the injection showed 17 characteristic peaks, and the peak areas percents of five were more than 5%. Taking the peak of ligustilide （ No. 16） as the reference,RSD of the relative retention time among 10 batches was less than 2. 6% ,and RSD of the relative areas over 5% was less than 1.5%. Conclusion：The specific（fingerprint） chromatogram of the injection with high specificity can be used to control its quality and assure batch to batch consistency.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第5期572-576,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
复方当归川芎注射液
高效液相色谱法
特定(指纹)图谱
composite injection of Radix Angelicae Sinensis and Rhizoma Chuanxiong
HPLC
specific （fingerprint） chromatogram
