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

目的建立高效液相色谱法（HPLC）测定缬沙坦胶囊溶出度的方法。方法采用《中国药典》2010年版中缬沙坦胶囊溶出度测定条件,以磷酸盐缓冲液（调节p H 6.8）1000 ml为溶出介质,100 r/min,30 min取样。液相色谱柱为Extend C18（4.6 mm×250 mm,5μm）,以乙腈-水-冰醋酸（500：500：1）（v/v）为流动相,检测波长：230 nm,流速：1.0 ml/min,柱温：30℃。结果缬沙坦在0.004～0.06 mg/ml范围内线性关系良好,线性方程为Y=28.771X-28.145（r=0.9997,n=8）,平均回收率为101.27%（RSD=1.07%,n=9）。HPLC与紫外-可见分光光度法（UV）溶出度测定结果有一致性。结论高效液相色谱法测定缬沙坦胶囊溶出度的方法准确度高、简便、快速,适用于该制剂的质量控制。

Objective To establish a high performance liquid chromatography（ HPLC） method to detect dissolution of Valsartan capsules. Methods Based on detection conditions in the Chinese Pharmacopoeia（ 2010 edition）,the dissolution of Valsartan capsules was detected by phosphate buffer（ p H 6. 8） 1000 ml as the dissolution medium with100 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 Valsartan 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.