Abstract
Objective: The current study focused on the development, validation, and characterization of forced degradation products using LC-MS/MS. Methods: A simple, selective, validated and well-defined isocratic HPLC methodology for the quantitative determination of Tucatinib at a wavelength of 239 nm. An isocratic elution of samples was performed on an Inertsil ODS (250x4.6 mm, 5m) column with a mobile phase of 70:30v/v Acetonitrile and formic acid (0.1%) delivered at a flow rate of 1.0 ml/min. MS/MS was used to characterize degradation products formed in the forced degradation study. The validation and characterization of forced degradation products were performed in accordance with ICH guidelines. Results: Over the concentration range of 5-100μg/ml, a good linear response was obtained. Tucatinib's LOD and LOQ were determined to be 0.05 and 0.5, respectively. According to standard guidelines, the method was quantitatively evaluated in terms of system suitability, linearity, precision, accuracy, and robustness, and the results were found to be within acceptable limits. The drug was degraded under acidic, alkaline, and reduction conditions in forced degradation studies. Conclusion: The method was found to be applicable for routine tucatinib analysis. Because no LC-MS/MS method for estimating tucatinib and its degradation products has been reported in the literature. There is a need to develop a method for studying the entire tucatinib degradation pathway.
Highlights
Tucatinib belongs to a class of drugs known as kinase inhibitors [1, 2]
Because no LC-Mass spectrometric (MS)/MS method for estimating tucatinib and its degradation products has been reported in the literature
There is a need to develop a method for studying the entire tucatinib degradation pathway
Summary
Tucatinib belongs to a class of drugs known as kinase inhibitors [1, 2]. Tucatinib's chemical name is N6-(4,4-dimethyl-4,5-dihydro-1,3oxazol-2-yl)-N4-(3-methyl-4-[1,2,4]triazolo[1,5-a]pyridin-7yloxyphenyl)quinazoline-4,6-diamine. Sold under the brand name Tukysa, is a small molecule inhibitor of HER2 for the treatment of HER2-positive breast cancer [3, 4]. It works by preventing the abnormal protein from signalling cancer cells [5, 6] to multiply. This aids in the prevention or slowing of the spread of cancer cells. In combination with trastuzumab and capecitabine, was approved by the FDA on April17, 2020 for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer
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