解放军医药杂志2015，Vol.27Issue(12)：109-112,4.DOI:10.3969/j.issn.2095-140X.2015.12.025
高效液相色谱法测定缬沙坦胶囊的溶出度
High Performance Liquid Chromatography in Determination of Dissolution of Valsartan Capsules
杨静 1徐轶飞 1苗爱东 1尹娜娜 2王文习3
作者信息
- 1. 100071北京,北京军区联勤部药品仪器检验所
- 2. 266101 山东 青岛,青岛市黄海制药有限责任公司
- 3. 050081 石家庄,白求恩国际和平医院药剂科
- 折叠
摘要
Abstract
Objective To establish a high performance liquid chromatography ( HPLC) method to detect disso-lution of Valsartan capsules. Methods Based on detection conditions in the Chinese Pharmacopoeia (2010 edition), the dissolution of Valsartan capsules was detected by phosphate buffer (pH 6. 8) 1000ml as the dissolution medium with 100 r/min, and samples were obtained after treatment for 30 min. Liquid chromatographic column was Extend C18 (4. 6 mm × 250 mm, 5 μm), mobile phase was composed of acetonitrile, water and glacial acetic acid [500: 500: 1 (V/V)], and the wavelength was 230 nm. The flow rate was 1. 0 ml/min with 30℃ column temperature. Results Val-sartan showed good linear correlation in the range of 0. 004-0. 06 mg/ml, and the linear equation was Y =28. 771X-28. 145 (r=0. 9997, n=8), and the average recovery was 101. 27% [relative standard deviation (RSD) =1. 07%, n=9]. The HPLC had concordance with ultraviolet and visible spectrophotometry (UV) in detection of the dissolution. Conclusion HPLC method in determination of the dissolution of Valsartan capsule is accurate, simple and quick, and it can be applied to the quality control of the preparation.关键词
缬沙坦胶囊/溶出度/高效液相色谱法Key words
Valsartan capsules/Dissolution/High performance liquid chromatography分类
医药卫生引用本文复制引用
杨静,徐轶飞,苗爱东,尹娜娜,王文习..高效液相色谱法测定缬沙坦胶囊的溶出度[J].解放军医药杂志,2015,27(12):109-112,4.
