Ecofriendly Densitometric (RP and NP) HPTLC Methods for Determination of Sorafenib in bulk and formulation

Abstract

The growing demand for sustainable analytical practices has emphasized the need for green methodologies in pharmaceutical analysis. Anticancer drugs require precise and efficient quality control due to their therapeutic significance and narrow therapeutic index. Conventional chromatographic methods often use toxic solvents, posing environmental and safety concerns. HPTLC offers a rapid, cost-effective alternative with reduced solvent usage. Specific, accurate, and sustainable RP-HPTLC and NP-HPTLC methods were developed and validated to assess SFB in bulk and pharmaceutical formulations, aligning with green analytical chemistry principles, ensuring regulatory compliance in routine quality control. We present a novel, simple, and effective approach for analysing SFB. Mobile phases composed of isopropanol: water: glacial acetic acid for RP-HPTLC and n-butanol: ethyl acetate for NP-HPTLC. Both methods demonstrated compact spots during evaluation in the absorbance mode at 265 nm, with Rf values of 0.54 ± 0.2 for RP-HPTLC and 0.7 ± 0.2 for NP-HPTLC. Regarding linearity, RP-HPTLC and NP-HPTLC exhibited an excellent correlation with an R² value of 0.9998 within 200–1000 ng/spot and 0.9993 across 200–1200 ng/spot, respectively. Both methods were validated following the ICH Q2 (R2) guidelines and successfully applied to estimate SFB in marketed formulations, yielding satisfactory results. The AGREEprep score for sample preparation was 0.77 for RP-HPTLC and 0.73 for NP-HPTLC, indicating a green sample preparation procedure. Furthermore, the AGREE tool scores for the validated methods were 0.83 for RP-HPTLC and 0.82 for NP-HPTLC, reflecting their high environmental sustainability. Our findings underscore the promise of green chromatographic methods in mitigating the environmental footprint of analytical practices, offering viable alternatives for pharmaceutical industries seeking to reduce hazardous organic solvent usage and adopt more sustainable, eco-friendly approaches.