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作 者:鄢琳[1] 李铜铃[1] 张蓉琴[1] 许小红[1] 郑鹏程[1] 胡亚敏[2]
机构地区:[1]四川大学华西药学院临床药学教研室,博士四川成都610041 [2]浙江大学第一附属医院药剂科,浙江杭州3100013
出 处:《中国药学杂志》2004年第4期303-304,共2页Chinese Pharmaceutical Journal
摘 要:目的 建立左羟丙哌嗪缓释片含量测定方法。方法 采用反相高效液相色谱法,色谱柱为Diamonsil C18柱(4.0mm×200mm,5μm),流动相:甲醇-0.05 mol·L-1二乙胺水溶液(20:80),磷酸调pH至3.0,紫外检测波长:240 mm。结果 左羟丙哌嗪在5.03-50.30,μg·mL-1内与峰面积呈良好线性关系,辅料对含量测定无干扰,平均回收率为99.93%,RSD为1.26%(n=9),方法 精密度实验RSD=0.79%(n=6)。结论 该法简便、准确、重复性好,适用于左羟丙哌嗪缓释片的含量测定。OBJECTIVE: To establish a HPLC method for determing the content of levodropropizine in sustained-relaese tablets. METHODS: The chromatographic condition was as following: Diamonsil C18 column (4.0 mm × 200 mm, 5 μm) was used; methanol and 0.05 mol · L-1 diethylamine solution (20:80, pH adjusted to 3.0 with H3 PO 4) was used as the mobile phase; the detection wavelength was 240 nm. RESULTS: The linear range was 5.03 - 50.30 μg· mL-1. The average recovery was 99.93% (RSD was 1.26%, n = 9); the RSD for reproducibility was 0.79% (n = 6). CONCLUSION: The proposed method is simple, rapid, accurate and can be used for the assay of levodropropizne sustained-release tablets.
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