摘要
目的建立HPLC替代对照品测定石杉碱甲片含量的测定方法。方法在不同的条件下测定替代对照品西咪替丁对石杉碱甲对照品的校正因子,利用校正因子和替代对照品西咪替丁进行石杉碱甲片的含量测定。结果石杉碱甲和西咪替丁分别在2.5～160mg.L-1(r=1.0000)和0.1～20.0mg.L-1(r=1.0000)内与峰面积呈良好的线性关系(n=7),测得校正因子f=2.3624,用替代对照品测定方法测得回收率为97.0%(n=5),RSD=1.7%。结论本实验首次在高效液相色谱仪上使用替代对照品测定了石杉碱甲片含量,结果证明,用替代对照品进行药品质量控制是可行的、实用的。
OBJECTIVE To establish and validate a HPLC method with a substitu：e for the reference substance for quantitative determination of Huperzine A tablets. METHODS Cimetidine was selected as the substitute for reference substance of huperzine A and the correction factor of cimetidine vs the reference substance of huperzine A was determined under different conditions. RESULTS Huperzine A tablets were quantified by assaying the substitute of cimitidine and the application of a correct factor. The result showed that calibration curves were linear in the ranges of 2.5 - 160 mg ·L^-1 （r = 1. 000 0） for huperzine A and 0. 1 -20. 0 mg·L^-1 （r = 1. 000 0） for cimetidine, respectively （n = 7）. The correction factor （f） was 2. 362 4. The overall recovery detected by the substitute for reference substance method was 97.0% （n = 5）, RSD = 1.7%. CONCLUSION The results indicated that the HPLC method of the substitute reference substance was reliable and feasible for quantitative determination in drug quality control.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2008年第3期217-221,共5页
Chinese Pharmaceutical Journal
关键词
替代对照品
校正因子
含量测定
石杉碱甲
西咪替丁
高效液相色谱法
substitute reference substance
correction factor
quantitative determination
huperzine A
cimetidine
HPLC
