中国药科大学学报2024，Vol.55Issue(4)：478-484,7.DOI:10.11665/j.issn.1000-5048.2023031302
普瑞巴林胃滞留缓释片含量测定及高黏性辅料对测定结果的影响
Determination of the content of pregabalin gastric retention sustained-release tablets and influence of high viscosity excipients on the determination results
刘娟 1庞跃成 2陈艳敏 2左淑航 2高永吉1
作者信息
- 1. 潍坊医学院,潍坊 261053
- 2. 华润双鹤利民药业(济南)有限公司,济南 250200
- 折叠
摘要
Abstract
A high-performance liquid chromatographic(HPLC)method for the assay of pregabalin gastric retention sustained-release tablets was established,successfully solving the problem of low recovery of pregabalin through a special sample pretreatment method.By comparing salting-out and excipient dispersion,the pretreatment methods to overcome the viscosity of the test solution were established.Both methods can be used for the determination of the product content,but the salting-out method is easier to operate.The HPLC conditions were Inertsil ODS-3(4.6 mm×0.25 m,5 µm)column with mobile phase of 3.4 g/L potassium dihydrogen phosphate(pH adjusted to 6.3 by ammonia)and methanol(85︰15);the column temperature was 30℃;the flow rate was 1.0 mL/min;the sample size was 50 µL;and the detection wavelength was 210 nm.Through the validation of the salting-out method,the average recovery of the drug was 99.74%and the RSD was 0.43%;the precision test RSD was 0.77%;the test solution was stable within 12 h;the chromatographic system had good durability;and the excipient did not interfere with the content detection.The method is stable,reliable and suitable for the assay of pregabalin gastric retention sustained release tablets.关键词
普瑞巴林/胃滞留缓释片/含量测定/高效液相色谱/盐析/辅料分散Key words
pregabalin/gastric retention sustained-release tablets/content determination/high performance liquid chromatography/salting-out/excipient dispersion分类
医药卫生引用本文复制引用
刘娟,庞跃成,陈艳敏,左淑航,高永吉..普瑞巴林胃滞留缓释片含量测定及高黏性辅料对测定结果的影响[J].中国药科大学学报,2024,55(4):478-484,7.
