Determination of sunitinib malate in nanoparticles formulation using hptlc-densitometry technique

The objective of the present work was to develop and validate a simple high-performance thin-layer chromatography (HPTLC) method for the estimation of an anticancer drug sunitinib malate (SM) in nanoparticles (NPs) formulation. The developed method was validated in accordance with International guidance on Harmonization (ICH) guidelines for precision, accuracy, specificity, sensitivity and robustness. The HPTLC estimation of SM was carried out by applying the ethyl acetate: Acetone: Water: Formic acid 15:5:2:2 (%, v/v/v/v) as the mobile phase on 20 x 10 cm glass coated silica gel 60 F254 plates. The estimation of SM was performed in densitometric mode at λ_max=423 nm. The data of linearity analy-sis presented a good linear relationship between the concentration of SM and HPTLC response over the concentration range of 100-700 ng/spot with R²=0.9991. The % amount of SM in prepared NPs was ob-tained as 98.41% by applying the proposed HPTLC technique. The proposed HPTLC technique was vali-dated well as per ICH recommendations. The results of validation studies and pharmaceutical assay sug-gested that the proposed HPTLC technique could be applied in wide range for the estimation of SM in pharmaceutical preparations.