HPLC法测定他米巴罗汀片的溶出度.pdfVIP

HPLC 法测定他米巴罗汀片的溶出度 ＊ 2 3# 陈丽姣 ，杨冬霞 ，赵艳霞 （1. 山东理工职业学院，山东济宁 272067；2. 山东创新药物研发有限公司，济南 250101；3. 山东省医学科学院研究生教育中心，济南 250062） 中图分类号 R927 文献标志码 A 文章编号2016 DOI 10.6039/j.issn.2016.30.42 摘 要 目的：建立测定他米巴罗汀片溶出度的方法。方法：采用高效液相色谱法。色谱柱为Diamonsil C18，流动相为甲醇水冰 乙酸（85∶15∶1，V/ V/ V），流速为1.0ml/min ，检测波长为235nm ，柱温为25℃，进样量为20μl。溶出度测定采用桨法，以pH6.8磷酸 盐缓冲液为溶出介质，溶出介质体积为900ml ，转速为50r/min ，60min 取样。结果：他米巴罗汀检测质量浓度线性范围为0.801～ 2.804μg/ml （r ＝0.9996）；精密度、稳定性、重复性试验的RSD ＜3％；回收率分别为99.58％～100.90％（RSD ＝0.25％，n ＝9）；3批 样品的溶出度测定结果分别为98.25％、96.54％、92.38％（n ＝6）。结论：该方法简便、准确，灵敏度高，专属性强，适用于他米巴罗 汀片的溶出度测定。 关键词 高效液相色谱法；他米巴罗汀片；溶出度 Dissolution Determination of Tamibarotene Tablet by HPLC 2 3 CHEN Lijiao ，YANG Dongxia ，ZHAO Yanxia （1.Shandong Polytechnic College ，Shandong Jining 272067，Chi- na ；2.Shandong Chuangxin Pharmaceutical Research and Development Co. Ltd. ，Jinan 250101，China ；3.Gradu- ate Education Center ，Shandong Academy of Medical Sciences ，Jinan 250062，China ） ABSTRACT OBJECTIVE ：To establish a method for the dissolution determination of Tamibarotene tablet. METHODS ：HPLC was performed on the column of Diamonsil C18 with mobile phase of methanol water acetic acid （85∶15∶1，V/ V/ V）at a flow rate of 1.0ml/min ，detection wavelength was 235nm ，column temperature was 25 ℃，and injection volume was 20 μl. The paddle method was used to determine the dissolution ，using pH6.8phosphate buffer dissolution as medium ，medium volume was 900ml ，the rotat ing speed was 50 r/min ，taking samples after 60 min. RESULTS ：The linear range of tamibarotene was 0.8012.804 μg/ml （r ＝ 0.9996）；RSDs of precision ，stability and reproducibility tests were lower than 3％；recovery was 99.58％ 100.90％ （RSD ＝