DEGRADATION STUDIES OF TRIPROLIDINE: ISOLATION, CHARACTERIZATION OF OXIDATIVE DEGRADATION PRODUCTS AND DEVELOPMENT OF A VALIDATED STABILITY INDICATING UHPLC METHOD.

Triprolidine was subjected to various stress conditions and degradation profile was studied with conventional LCMS. Interestingly, under oxidative stress conditions the drug substance underwent distinct transformation to give rise to two major degradation products. The structure of these products was elucidated using 1D, 2D NMR spectroscopy, and high resolution mass spectrometry (Q-TOF LC/MS) and found to be Triprolidine N-Oxide and Pyridin-2-yl-p-tolyl-methanone. An efficient stability indicating MS compatible ultra high performance liquid chromatographic (UHPLC) separation method was developed for triprolidine and three degradation products (including Z-Triprolidine) using 1.8 µm, C18 reverse phase column. Baseline separation was achieved with a run time of four minutes. The separation method has been validated for the assay of triprolidine and its related substances with respect to system suitability, specificity, limit of detection, limit of quantification, linearity, range, precision, accuracy, and robustness. [ABSTRACT FROM AUTHOR]