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In Vitro Drug Release Testing: Overview, Development and Validation

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Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers

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Development and Validation of a Robust RP-HPLC Method for Quantifying Dasatinib in Self-Microemulsifying Drug

Nitin V Kokare¹, Rohit R Shah², Rana Salman Saad Al-Rashidi³

¹Department of Quality Assurance, Appasaheb Birnale College of Pharmacy, Sangli, 416416, Maharashtra, India.

International Journal of Analytical Chemistry

|February 4, 2026

Summary

A new reverse-phase high-performance liquid chromatography (RP-HPLC) method accurately quantifies dasatinib in self-microemulsifying drug delivery systems (SMEDDSs). This validated method enhances dasatinib bioavailability for chronic myeloid leukemia treatment.

Keywords:

dasatinib drug design formulation reverse-phase HPLC stability validation

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Area of Science:

Pharmaceutical Sciences
Analytical Chemistry

Background:

Dasatinib, a chronic myeloid leukemia (CML) therapy, exhibits poor oral bioavailability.
Self-microemulsifying drug delivery systems (SMEDDSs) are investigated to enhance dasatinib dissolution and bioavailability.

Purpose of the Study:

To develop and validate a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative analysis of dasatinib.
To assess the suitability of the developed RP-HPLC method for dasatinib quantification within SMEDDS formulations.

Main Methods:

A RP-HPLC method was established using a methanol and 0.1% trifluoroacetic acid mobile phase (55:45, v/v) with detection at 324 nm.
Dasatinib quantification in SMEDDS formulations (Capryol 90, Transcutol HP, Tween 40) was performed.
Method validation was conducted according to International Council for Harmonisation (ICH) guidelines.

Main Results:

The RP-HPLC method demonstrated excellent linearity (R² = 0.9993), accuracy (98-101% recovery), and precision (RSD = 0.73%).
The method exhibited robust stability and reliability with low limits of detection (0.17 µg/mL) and quantification (0.50 µg/mL).

Conclusions:

The developed RP-HPLC method is validated and suitable for quantifying dasatinib in SMEDDS formulations.
This robust and cost-effective analytical tool supports the development and quality control of dasatinib-loaded SMEDDS.