Development and Validation of Stability Indicating HPLC Isocratic Method of Dota and Family Compounds for its Qualitative and Quantitative Analysis in Bulk Drug Use in Green Mobile Phase

Abstract

The previously described gradient elution and complex mobile phase HPLC techniques for determining gemcitabine are time-consuming. The goal of this work is to create an efficient HPLC technique for the simultaneous determination of DOTA and associated compounds utilized as intermediates in the manufacture of API. as part of an API, researching the manufacture of DOTA and related compounds at various stages (such as CYCLEN, DODIA, and DOTRA) These findings show the usefulness and potency of this straightforward isocratic HPLC technique in assessing the general performance of a formulation containing gemcitabine.

Keywords: Development, Stability, Hplc, Dota, Drug and Mobile Phase