高效液相色谱法测定盐酸丁咯地尔亲水凝胶骨架缓释片中主药含量

Content Determination of Buflomedil Hydrochloride in Buflomedil Hydrochloride Hydrophilic Matrix Sustained-Release Tablets by HPLC

目的建立测定盐酸丁咯地尔亲水凝胶骨架缓释片中主药含量的高效液相色谱法。方法以C18柱(250 mm×4.6mm,5μm)为色谱柱,流动相为甲醇-0.05mol/L磷酸二氢钠溶液(30∶70),检测波长为282 nm,流速为1 mL/min,柱温为30℃,进样量为20μL。结果盐酸丁咯地尔进样量在1.042～6.252μg(r=0.999 7)范围内与峰面积有良好的线性关系,平均回收率为100.34%,RSD=1.71%(n=9)。结论所用方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective To establish a method for the determination of buflomedil hydrochloride in Buflomedil Hydrochloride Hydrophilic Matrix Sustained-Release Tablets.Methods HPLC was performed on a C18 column using mathanol-0.05 mol/Lsodium dihydrogen phosphate（30 ∶70） as the mobile phase at a flow rate of 1 mL/min.The detection wavelength was at 282 nm.The column temperature was 30 ℃and the sample size was 20 μL.Results The linear range of buflomedil hydrochloride was 1.042-6.252 μg（r=0.999 7）,the average recovery was 100.34%,RSD=1.71%（n=9）.Conclusion The method is simple,accurate,special and can be used for the quality control of Buflomedil Hydrochloride Hydrophilic Matrix Sustained-Release Tablets.