RP-HPLC法测定丙戊酸钠缓释片的释放度  

Determination of Release of Sodium Valproate Sustained-Release Tablets with RP-HPLC

作　　者：李舸远[1] 蔡美明[1] 王玉[1] 

机构地区：[1]江苏省食品药品检验所,南京210008

出　　处：《中国药品标准》2011年第3期195-198,共4页Drug Standards of China

摘　　要：目的:建立测定丙戊酸钠缓释片释放度的反相离子对色谱法,并与已有滴定方法进行比较。方法:采用SHIMADAZU VPC18色谱柱,以0.12%四丁基氢氧化铵缓冲液(含0.02 mol.L-1磷酸二氢钾,用10%磷酸调节pH值至6.0)-甲醇(50∶50)为流动相,流速1.0 mL.min-1,检测波长207 nm。结果:HPLC法测定丙戊酸钠在50～600μg.mL-1浓度范围内线性关系良好r=0.999 9,平均回收率为99.7%(n=9),RSD为0.4%。测定3批样品结果HPLC法与《中国药典》的滴定方法无显著性差异。结论:所建方法准确、方便,可作为丙戊酸钠缓释片释放度的药典测定方法。Objective： To develop a RP-HPLC with ion pairs method for the determination of release of Sodium Valproate Sustained-release tablets and compare with the reported titration method. Methods： A SHIMADAZU VP C18 column was used with the mixture of 0. 12% tetrabutylammonium hydroxide buffer fluid（ contains 0. 02 mol · L^- 1 potassium dihydrogen phosphate solution with using 10% phosphoric acid adjust the fluid to pH 6.0） and methanol （ 50：50 ） as mobile phase, the flow rate is 1.0 mL · min^ - 1, the wavelength of UV detector is 207 nm. Results： The calibration curve was linear in the range of 50 -600 μg · mL^-1 , r =0. 999 9. The average recovery was 99. 7% （n = 9）, RSD = 0. 4%. And the results has no apparent differences compared with titration method of Chinese Pharma- copeia. Conclusion ： The proposed RP-HPLC with ion pairs method was convenient and accurate for the determination of release of So- dium valproate sustained-release tablets. It can be used as a standard method of Chinese Pharmacopeia.

关 键 词：反相离子对色谱法 丙戊酸钠缓释片 释放度 F检验 

分 类 号：R921.2[医药卫生—药学]