# Development and Validation of a Robust RP‐HPLC Method for Quantifying Dasatinib in Self‐Microemulsifying Drug Delivery Systems

## TL;DR

A new and reliable method was developed to measure dasatinib in drug delivery systems, improving its effectiveness for treating chronic myeloid leukemia.

## Contribution

A validated RP-HPLC method was developed for accurate quantification of dasatinib in SMEDDS formulations.

## Key findings

- The RP-HPLC method showed excellent linearity (R² = 0.9993), accuracy, and precision.
- The method has detection and quantification limits of 0.17 and 0.50 µg/mL, respectively.
- The method is stable, reliable, and cost-effective for analyzing dasatinib in SMEDDS.

## Abstract

Dasatinib, a therapy for chronic myeloid leukemia, suffers from poor bioavailability. Self‐microemulsifying drug delivery systems (SMEDDSs) are used to improve its dissolution. This study aimed to develop and validate a novel reverse‐phase high‐performance liquid chromatography (RP‐HPLC) method for quantifying dasatinib in SMEDDS formulations. The RP‐HPLC method utilized a mobile phase of methanol and 0.1% trifluoroacetic acid (55:45, v/v) and identified a peak wavelength for dasatinib at 324 nm. SMEDDS formulations comprised Capryol 90, Transcutol HP, and Tween 40. The method was validated according to ICH guidelines, demonstrating excellent linearity (R
2 = 0.9993), accuracy (recovery between 98% and 101%), and precision (relative standard deviation of 0.73%). It also showed stability and reliability with limits of detection and quantification of 0.17 and 0.50 µg/mL, respectively. This RP‐HPLC method meets all validation criteria and provides a robust, cost‐effective tool for analyzing dasatinib in SMEDDS formulations.