Identification, isolation and quantification of unknown impurity in tolterodine tartrate tablets by stability indicating HPLC method

ABSTRACT:

A sensitive gradient reverse phase high performance liquid chromatography (HPLC) method development for identification and quantification of impurities in pharmaceutical products is a challenging and innovative activity. The present investigation aims to the identification of new unknown impurity of Tolterodine tartrate formed in stability samples of the drug product at a level up to 0.5% by using a stability indicating HPLC method. This impurity molecular weight was identified by LC-MS and characterized by various spectroscopic techniques such as 1H NMR, 13C NMR, LC/MS/MS, elemental analysis and FT-IR. Based on the data obtained from spectroscopic tools, the impurity was named as, 6-methyl-4-phenylchroman-2-ol. The structure of this impurity was also established unambiguously, prepared by isolation and co-injected into HPLC to confirm the retention time. To the best of our knowledge, this impurity has not been reported elsewhere. Structural elucidation of the impurity by spectral data is discussed in detail.



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