LC and LC-MS/MS Studies for the Characterization of Forced Degradation Products of Tucatinib, a Novel Tyrosine Kinase Inhibitor| Chapter 3 | Challenges and Advances in Pharmaceutical Research Vol. 10

 The happening, validation, and characterisation of compulsory degradation products utilising LC-MS/MS were the main aims of the current investigation.Using an isocratic HPLC approach, tucatinib maybe measured quantitatively at a awareness of 239 nm in a simple, selective, substantiated, and well-defined method. An isocratic elution of samples was performed on an Inertsil ODS (250x4.6mm, 5m) procession with a mobile aspect of 70:30v/v Acetonitrile and formic acid (0.1%) delivered at a flow rate of 1.0 mL/brief time period. The degradation amount created during the strained degradation inquiry were characterised using MS/MS. Over the aggregation range of 5-100μg/ml, a good linear answer was obtained. Tucatinib's LOD and LOQ were determined expected 0.05 and 0.5, respectively. The approach was quantitatively determined in terms of order appropriateness, linearity, accuracy, accuracy, and strength in accordance with standard directions, and the findings were found expected within satisfactory limits. In studies on forced degeneration, the medication decomposed in sour, alkaline, and decline environments. It was persistent that the approach could be used for standard tucatinib study. Since there hasn't happened any evidence of an LC-MS/MS design for quantifying tucatinib and its degradation fruit in the literature. A device for researching the complete tucatinib degradation process has to be grown.

Author(s) Details:

S. K. Reehana,
Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Acharya Nagarjuna University; Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India.

K. Sujana,
Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Acharya Nagarjuna University; Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India.

A. Suneetha,
Department of Pharmaceutical Analysis, KVSR Siddhartha College of Pharmaceutical Sciences; Vijayawada – 520010, Andhra Pradesh, India.

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