摘要
目的建立复方罗布麻片Ⅱ中盐酸异丙嗪的含量测定方法。方法采用RP—HPLC法测定。Thermo C18柱（250mm×4．6mm，5um），流动相为甲醇-磷酸盐缓冲液（60：40），流速1．0ml·min^-1，检测波长250nm。样品按国家食品药品监督管理局药品标准Ⅲ处理。结果线性范围：10～35mg·L^-1（r=0．9995）。精密度：RSD为0．27％（n=6），平均回收率为99．7％。结论试验表明，该方法简单，快速，结果准确，重现性好，可用于该制剂的质量标准检测。
Aim To develop a method for determining content of promethazine hydrochloride in tablets of fu fang luobuma Ⅱ by HPLC. Methods HPLC was used with C18 column. The mobile phase was methanol-phosphate PBS （ pH 3.0 ） （ 60：40 ）, and detection wavelength was 250 nm with a flow rate of 1.0 ml · min^-1. The sample was dealt with drug standard of State Food and Drug Administration, P. R. China. Results The linearity was obtained over the range of 10 -35 mg·L^-1 （ r = 0.9 995 ）. The average recovery was 99.7% and RSD was 0.27% （ n = 6 ）. Conclusion This method is simple, rapid, accurate and can be used for the quality control of tablets of fu fang luobuma Ⅱ.
出处
《安徽医药》
CAS
2009年第2期164-165,共2页
Anhui Medical and Pharmaceutical Journal
关键词
复方罗布麻片Ⅱ
盐酸异丙嗪
含量测定
HPLC
tablets of fu fang luobuma Ⅱ
promethazine hydrochloride
determination
HPLC
