Method Development and Quantification of Telmisartan by LC-MS.

      Аннотация: Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability and to provide information about degradation pathways and degradation products.The impurity profiling of the pharmaceuticals is of increasing importance as drug safety receives more and more attention from the public and from the media.LC?PDA method enables simple, accurate, reproducible and fast quantitative analysis of telmisartan in presence of degradation products. The method has been successfully applied to stability study. For quantification the training has helped in learning to develop a new, rapid, sensitive and precise MRM LC-ESI-MS-MS method for the simultaneous separation and quantification pharmaceutical drug telmisartan and its marketed formulation. The HPTLC method is sensitive, precise and accurate and can be used for the routine quality control analysis of telmisartan in its tablet dosage forms.

Ключевые слова: HPTLC, LC-MS, method development, Telmisarten, Force Degradation method