Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research NIPER, Sector 67, SAS Nagar 160 062, Punjab, India.
J Pharm Biomed Anal. 2010 Nov 2;53(3):755-61. doi: 10.1016/j.jpba.2010.05.005. Epub 2010 May 8.
Telmisartan, an anti-hypertensive drug, was subjected to stress studies under ICH prescribed conditions of hydrolysis (acidic, neutral and basic), photolysis, oxidation and thermal stress. The drug showed labiality under only photo-acidic condition by forming a single degradation product. HPLC separation of the drug and the degradation product was achieved on C-8 column using gradient method. To characterize the product, a complete mass fragmentation pathway of the drug was initially established. Subsequently, the degradation product peak was subjected to LC-MS/TOF and on-line H/D exchange mass studies. Based on these studies, a tentative structure was assigned to the product as 3-((1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzo[d]imidazol-3'-yl)methyl)-6H-benzo[c]chromen-6-one, which was verified through (1)H LC-NMR experiments.
替米沙坦是一种降压药，根据 ICH 规定的水解（酸、碱和中性）、光解、氧化和热应力条件进行了稳定性研究。该药物仅在光-酸性条件下通过形成单一降解产物表现出不稳定性。采用梯度法在 C-8 柱上用 HPLC 分离药物和降解产物。为了对产物进行表征，首先建立了药物的完整质谱裂解途径。随后，对降解产物峰进行 LC-MS/TOF 和在线 H/D 交换质谱研究。基于这些研究，将产物的暂定结构分配为 3-((1,7'-二甲基-2'-丙基-1H,3'H-2,5'-二苯并[d]咪唑-3'-基)甲基)-6H-苯并[c]色烯-6-酮，通过（1）H LC-NMR 实验得到了验证。
