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RP-LC Method Development and Validation for Dasatinib Forced Degradation Study: Isolation and Structural

Dasameswara Rao Kavitapu1, Jayanti Naga Sri Rama Chandra Murty2, Arthanareeswari Maruthapillai1

  • 1Department of Chemistry, SRM Institute of Science and Technology, Kattankulathur 603203, Tamil Nadu, India.

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Summary

A new high-performance liquid chromatography (HPLC) method accurately quantifies Dasatinib (DST) and its impurities in pharmaceuticals. This stability-indicating method identifies and characterizes unknown acid and oxidative degradation products, ensuring drug quality and safety.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Chromatography

Background:

  • Accurate quantification of active pharmaceutical ingredients (APIs) and their impurities is crucial for drug safety and efficacy.
  • Dasatinib (DST) is a vital pharmaceutical agent, necessitating robust analytical methods for quality control.
  • Existing methods may not adequately separate and identify all process-related and degradation impurities.

Purpose of the Study:

  • To develop and validate a stability-indicating reverse-phase high-performance liquid chromatography (HPLC) method for quantifying Dasatinib (DST) and its impurities.
  • To identify and characterize major degradation products of Dasatinib under various stress conditions.
  • To ensure the reliability and suitability of the developed HPLC method for routine pharmaceutical analysis according to ICH guidelines.

Main Methods:

  • Development of a reverse-phase HPLC method using a Kinetex C18 column.
  • Optimization of chromatographic conditions including mobile phase composition (buffer and acetonitrile), flow rate (0.9 mL/min), column temperature (45°C), and gradient elution.
  • Forced degradation studies under acidic, alkaline, oxidative, photolytic, and thermal conditions; isolation and characterization of impurities using preparative HPLC, high-resolution mass spectrometry, nuclear magnetic resonance spectroscopy, and Fourier transform infrared spectroscopy.

Main Results:

  • A gradient elution method on a Kinetex C18 column provided symmetric and well-resolved peaks for DST and its impurities.
  • Two major impurities were identified: an unknown acid degradation product (C22H25Cl2N7O2S) and DST N-oxide Impurity-L (oxidative degradant).
  • The method demonstrated excellent stability-indicating capability, with successful validation as per ICH guidelines.

Conclusions:

  • The developed HPLC method is suitable for the accurate quantification of Dasatinib (DST) and its impurities in pharmaceutical formulations.
  • The characterization of degradation products provides valuable insights into the stability profile of Dasatinib.
  • This validated analytical method ensures the quality control and safety of Dasatinib-containing pharmaceutical products.