A developed HPLC method for the determination of Alogliptin Benzoate and its potential impurities in bulk drug and tablets  

作　　者：Kun Zhang Panqin Ma Wenna Jing Xiangrong Zhang 

机构地区：[1]School of Pharmacy,Shenyang Pharmaceutical University,No.103,Wenhua Road,Shenyang,110016,China [2]Kangya of Ningxia Pharmaceuticals CO.LTD,No.57,Fuan West Lane,Yinchuan,750003,China [3]School of Medical Devices,Shenyang Pharmaceutical University,No.103,Wenhua Road,Shenyang,110016,China

出　　处：《Asian Journal of Pharmaceutical Sciences》2015年第2期152-158,共7页亚洲药物制剂科学（英文）

摘　　要：Alogliptin(AGLT),active ingredient of Alogliptin Benzoate(AGLT-BZ),is a new dipeptidyl peptidase-4(DPP-4)inhibitor for the treatment of type 2 diabetes.This study aimed to build a suitable method to determine the potential related substances in AGLT-BZ bulk drug and tablets.Seven related substances in Alogliptin Benzoate substances were synthetized and identified by ^(1)H-NMR and ESI-MS.In addition,the impurities were detected by a gradient reverse-phase high performance liquid chromatography(RP-HPLC)with UV detection.The chromatographic system consisted of an Angilent Zobax SB-CN column(250×4.6 mm;5 μm).The mobile phase consisted of water/acetonitrile/trifluoroacetic acid 1900:100:1 v/v/v(solution A)and acetonitrile/water/trifluoroacetic acid 1900:100:1 v/v/v(solution B)using a gradient program at a flow rate of 1.0 ml/min with 278 nm detection and an injection volume of 20 ml.Additionally,selectivity,the limit of quantitation(LOQ)and limit of detection(LOD),linearity,accuracy,precision and robustness were determined.Linearity was good over the concentration range 50-1000 ng/ml and the coefficient of determination(R^(2))were 0.9991-0.9998.RSD% of the determination of precision were <2%(n=6).The method of RP-HPLC for the determination of impurities in AGLT-BZ was proved to be precise,accurate,robust and reliable.Three batches of self-made bulk drug and three dosages of commercial tablets were detected with this method.

关 键 词：Alogliptin benzoate Impurity HPLC Bulk drug Commercial tablets 

分 类 号：R97[医药卫生—药品]