HPLC测定维拉帕米栓中盐酸维拉帕米的含量

Determination of Verapamil Hydrochloride in Verapamil Suppositories by HPLC

目的建立高效液相色谱法测定维拉帕米栓中盐酸维拉帕米的含量。方法以Dianmonsil^TM（钻石）（250mm×4．6mm，5μm）C18为色谱柱，醋酸-醋酸钠溶液：甲醇：三乙胺（45：55：1）为流动相，紫外检测波长为278nm。结果盐酸维拉帕米在0．4～2．0mg·mL^-1内线性关系良好（r=0.9998），平均回收率为101．41％，RSD=2．05％（n=9）。三批维拉帕米栓中盐酸维拉帕米的标示含量分别为106.81％，101．01％，98．61％。结论本方法操作简便、快捷，结果准确、可靠，适用于维拉帕米栓的质量控制。

OBJECTIVE To establish high performance liquid chromatography method for determinating the content of verapamil hydrochloride in verapamil suppositories. METHODS A Dianmonsil^TM （250 mm× 4. 6 ram,5 μm） C18 column was used with the mobile phase of acetic acid-acetic natrium： methanol： three-ethylamine （45：55： 1） and UV wavelengh was 278 nm. RESULTS The calibration curve of verapamil hydrochloride was linear in the concentration range of 0. 4 - 2. 0 mg· mL^-1 （ r = 0.999 8）. The average recovery was 101.41% ,RSD = 2. 05% （n =9）. The relative content of verapamil hydrochloride in three batch of verapamil suppositories was 106. 81% , 101.01% and 98.61% , respectively. CONCLUSION This method is simple, quick, accurate and suitable for the quality control of verapamil suppositories.