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盐酸坦索罗辛缓释片含量和释放度测定方法研究
作者: 颖1 伍良涌1 谭文非2 
单位:1. 广州市药品检验所,广东广州510160;2. 广东药学院,广东广州510006
关键词:盐酸坦索罗辛缓释片 含量 释放度 高效液相色谱法 
中图分类号:R927
文献标志码:A
出版年,卷(期):页码:2013,23(1):26-29,
收稿日期:2012 -08 -09
摘要:
目的建立盐酸坦索罗辛缓释片含量和释放度测定方法。方法采用高效液相色谱法,以十八烷基硅烷键合硅胶为填充剂,乙腈- 高氯酸溶液(3∶7)为流动相,在225 nm 波长处检测,用外标法计算盐酸坦索罗辛缓释片含量;释放度照释放度测定法(《中国药典》2010 年版二部附录XD 第一法),采用溶出度测定法第一法的装置,以0. 1 mol/ L 的盐酸溶液500 mL[含聚山梨酯80 溶液(3→200)1mL]为溶剂,溶出2 h 后取样。然后在每个溶出杯中加入磷酸三钠9. 503 g 和20%氢氧化钠溶液3. 0 mL,继续溶出1 h 与3 h 取样,照含量测定项下的色谱条件测定,用外标法计算各时间点的累积释放百分率。结果含量在0. 503 ~4. 024 μg/ mL(r =0. 999 9,n =6)浓度范围内有良好的线性关系,平均回收率为101. 25%(RSD =2. 0%,n =9);样品在2 h 的释放量为12% ~39%,在3 h 和5 h 的累积释放量分别为44% ~70%和70%以上。结论该方法简便、准确,适用于测定盐酸坦索罗辛缓释片的含量和释放度。
Objective To establish a method for content and releasing rate determination of Tamsulosin Hydrochloride sustained release tablets. Methods A HPLC method was established on C18 column with a mobile phase of acetonitrile perchloric acid solution (3∶7) and detection wavelength was set at 2 55 nm. The concentration was quantified by external standard. The dissolution test method of Ch. P (2010) VolⅡAppendix XD was used in the study. The dissolution test was performed according to Ch. P (2010) dissolution test apparatus玉. To 500 mL of 0. 1 mol/ L hydrochloric acid solution add 1 mL of polysorbate 80 aqueous (3 g in 200 mL of water) as acid stage medium. After 2 h the sample was collected,and then dissolve 9. 503 g monobasic potassium phosphate in each dissolution vessel, add 3 mL of 20% sodiumⅠhydroxide. After 1 h and 3 h the sample was collected. Proceed as directed in the assay, The accumulated releasing rate was quantified by external standard. Results The calibration curve of content was linear in the range of 0.503 -4.024 μg/mL (r =0. 999 9, n =6). The average recovery was 101. 25% with RSD of 2. 0%. The accumulated release rate of 2, 3 and 5 h were 12% -39%, 44% -70% and above 70% respectively. Conclusion The method is simple and accurate,and can be used for the determination of content and releasing rate of tamsulosin hydrochloride sustained release tablets.
基金项目:
作者简介:
杨 颖,副主任药师,Tel: 020 -26282199, E-mail: elaineyyzty@163. com
通讯作者:
参考文献:
[1] 黄蓓蓓,卢建宏,肖佳尚. HPLC 法测定盐酸坦索罗辛口腔崩解片的含量及有关物质[J]. 中国药师,2011,14(4):499 -501.
[2] 金兰. 两种选择性琢受体阻断剂在治疗前列腺增生症中的疗效比较[J]. 江苏药学与临床研究,1999,7(1):31.
[3] 刘丽鹤,王鹏,李好枝. 盐酸坦洛新血药浓度测定方法及其药动学进展[J]. 中国药学杂志,2003,38(7):488-490.
[4] USP ( 美国药典) Tamsulosin Hydrochloride Capsules[S]. 35 版. 2012,4746 -4754.
[5] BP(英国药典)Prolonged - release Tamsulosin Capsules[S]. 2012 版. 2012,3325 -3326.
[6] WS1鄄(X鄄333)鄄2003Z[S],盐酸坦索罗辛缓释胶囊(国家药品标准).
[7] X960229[S],盐酸坦索罗辛缓释胶囊(进口药品注册标准).
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