STABILITY INDICATING VALIDATED RELATED SUBSTANCE UFLC METHOD & ALKALI DEGRADATION IMPURITIES CHARACTERIZED BY LCMS FOR IRBESARTAN IN BULK AND PHARMACEUTICAL FORMULATION PRODUCT

D Eswaramoorthy
2014 JGTPS   unpublished
This work emphasis the base decomposition of the Irbesartan and identification of new impurity determined by Ultra speed separation (UFLC) technique. The stress studies were carried out as per ICH guidelines Q1A R2, Q1B for the Irbesartan i.e., Hydrolytic, Oxidative, Photolytic and Thermal stress. A simple, highly economic, rapid, and sensitive reversed phase Ultra fast liquid chromatographic method developed for Irbesartan with potential impurities and degradation impurities. The
more » ... . The chromatographic separation for five impurities and three new degradation impurities were achieved by using Rapid resolution Symmetry C18 2.1 x 50mm, 1.7µm. This method is applicable of Irbesartan both in the bulk and formulations. The newly developed method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.
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