Sustainable quantitative analysis of Dasatinib Monohydrate using green RP- and NP-HPTLC methods in API and formulation with greenness evaluation by AGREE tool

Abstract

For the assessment of Dasatinib monohydrate (DST) in bulk and pharmaceutical formulations, specific, accurate, and sustainable reverse phase and normal phase high-performance thin-layer chromatographic (RP- and NP-HPTLC) methods were developed and validated. The mobile phase for RP and NP-HPTLC were composed of 2-propanol:water:glacial acetic acid (60:40:0.2, v/v/v) and methanol:n-butylacetate:glacial acetic acid (50:50:0.2, v/v/v), respectively. For the RP-HPTLC (R_f value of 0.31 ± 0.2) and NP-HPTLC (R_f value of 0.39 ± 0.2) techniques, it was observed that both methods produced compact and dense spots during densitometric evaluations in the reflectance-absorbance mode at 323 nm. In the concentration range of 30–500 ng/spot, RP-HPTLC demonstrated linear regression analysis in the calibration plot with an R² value of 0.9998. Similarly, NP-HPTLC also showed a strong linear relationship in the calibration plot with an R² of 0.9995 in the concentration range of 200–1200 ng/spot. The developed methods were validated for various parameters like specificity, accuracy, robustness, and recovery as per the ICH guideline Q2(R1). Both methods were employed for the estimation of DST in marketed formulation and satisfactory results were obtained. The AGREE tool was implemented for the assessment of greenness and AGREE scores of 0.9 and 0.88 were achieved for RP and NP-HPTLC methods, respectively reflecting the extreme greenness of both methods. These emerging and sustainable environmentally friendly green methods could be explored in pharmaceutical industries to protect nature from the potential hazards of organic solvents.