HPLC法测定克拉维酸钾有关物质

Determination of Related Substances in Clavulanate Potassium by HPLC

建立HPLC法，以进一步用液相色谱-质谱联用技术检查并推证克拉维酸钾中的有关物质。采用HPLC法测定，液相色谱条件为：采用ZORBAX ODS色谱柱，流动相A为0.01mol.L^-1乙酸铵，流动相B为流动相A-乙腈（1∶1），流速：1mL.min^-1，检测波长：230nm。克拉维酸钾浓度在5-160μg.mL^-1范围内与峰面积呈良好线性关系（r=0.9999），最低检测限为0.3μg.mL^-1。本法简便、准确、灵敏度高，适用于克拉维酸钾中有关物质的测定。

HPLC methods was established in order to detect and identify the related substances in clavulanate potassium by HPLC/MS. The HPLC system consisted of C18 column, 0.01mol·L^-1ammonium acetate as mobile phase A, 0.01mol·L^-1 ammonium acetate-acetonitrile （1 ： 1） mixture as mobile phase B, detection wave at 230nm, 1mol·L^-1 of flow rate and column temperature at 40 ℃, washing with graient. The linear range of clavulanate potassium was from 0.8ug·L^-1 to 8ug·L^-1 , r=0. 9999. The lowest detection limit was 0.3ug·L^-1 . This method is simple, accurate, sensitive and suitable for the as- say on the related substances of clavulanate potassium.