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A validated LC method for imatinib mesylate.

V V Vivekanand¹, D Sreenivas Rao, G Vaidyanathan

¹Department of Analytical Research, Dr Reddy's Laboratories Ltd., Discovery Research, Bollaram Road, Miyapur, Hyderabad 500 050, India.

Journal of Pharmaceutical and Biomedical Analysis

|December 6, 2003

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A new liquid chromatography method accurately assesses imatinib mesylate purity, detecting trace impurities in bulk drug substances. This validated method ensures drug quality and safety for pharmaceutical applications.

Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Imatinib mesylate is a critical pharmaceutical agent.
Ensuring the purity of bulk drug substances is essential for therapeutic efficacy and patient safety.

Purpose of the Study:

To develop and validate a selective analytical method for imatinib mesylate purity evaluation.
To detect and quantify process intermediates and related impurities in imatinib mesylate bulk drug.

Main Methods:

Isocratic reversed-phase liquid chromatography (RP-LC) with UV detection.
Utilized a Symmetry Shield RP18 analytical column.
Optimized mobile phase: 30 mM sodium octane sulphonic acid in 10 mM aqueous KH2PO4 (pH 2.5): Methanol (42:58 v/v) at 1.0 mL/min flow rate.
Detection wavelength set at 237 nm.

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Main Results:

The developed RP-LC method demonstrated high selectivity for imatinib mesylate.
The method effectively detected trace levels of process intermediates and related compounds.
Full method validation was performed, confirming system precision, method precision, linearity, accuracy, LOD, and LOQ.

Conclusions:

A robust and validated isocratic RP-LC method is established for imatinib mesylate purity assessment.
This analytical technique is suitable for routine quality control of imatinib mesylate bulk drug.
The method ensures the detection of potential impurities, contributing to pharmaceutical product safety.