摘要
目的建立薄膜衣片剂中食用色淀的HPLC含量测定新方法。方法高效液相色谱梯度洗脱法。色谱柱：Alltima-C18（4．6mm×250mm，5μm）；流动相：甲醇（A）-0．05mol·L^-1醋酸铵水溶液（B）梯度洗脱；检测波长：254nm；流速：1．0mL·min^-1；进样量为20此。结果柠檬黄色素和日落黄色素分别在10．03～200．6μg·mL^-1和10．01—200．2μg·mL^-1范围内呈良好线性关系（r≥0．9999），色淀总的平均回收率为96．7％，RSD=1．26％。结论所建立的方法操作简便、灵敏度高、重复性好，为薄膜衣片剂中食用色淀含量提供有效的质量控制，建立了新的检测方法。
OBJECTIVE To develop an HPLC method for the determination of content of edible lake in film-coated tablets. METHODS The analysis was carried on a column of Cls （Alltima-C18 ,4.6 mm × 250 mm,5 μm） by HPLC, with gradient elution of methanol（A）-0.05 mol · L^-1 ammonium acetate（B） as the mobile phase. The flow rate was 1.0 mL · min^-1. The detection wavelength was 254 nm, and the sample injection volume was 20 μL. RESULTS The linearity range of Tartrazine was 10.03 - 200.6 μg · mL^-1 and the linearity range of Sunset yellow was 10.01 -200.2 μg · mL^-1, the average recovery was 96.7% and the relative standard deviation（RSD） was 1.26%. CONCLUSION The method is simple, sensitive, accurate, reproducible, and can be used to control the quality of edible Lake in film-coated tablets.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2008年第4期340-343,共4页
Chinese Journal of Modern Applied Pharmacy
