Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF NOVEL ANTICANCER DRUG REGORAFENIB MONOHYDRATE IN BULK AND MARKETED FORMULATIONS

M. S. Sakriya, Y. Anand Kumar and K. M. Lokamatha Swamy*

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Abstract

The aim of the study was to develop and validate a novel anticancer drug regorafenib monohydrate (RGF MH) for estimation in pure form and in commercially availble marketed tablets. A simple, accurate, precise and rapid UV Spectrophotometric method was developed using methanolic HCl (solvent A) and acetonitrile:methanol (solvent B). The developed method was extensively validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantification according to ICH Q2 (R1) guidelines. Statistical validation included recovery studies for accuracy, linearity, precision, repeatability, and reproducibility. The absorption maxima at 261 nm and 263 nm for solvent A and solvent B respectively, demonstrated linearity within the range of 1-14 μg/ml, with robust correlation coefficients (R2 = 0.9998 and 0.9999) and recovery rates between 100 to 101.1%. The P-value (< 0.0001) exhibited the statistical significance of the proposed method. Both solvents A and B demonstrated precision and reproducibility, with relative standard deviation values (< 1). Stability studies indicated that the drug remained stable within acceptable limits over a period of 24 h. The developed approach was applied to commercially available tablets of RGF MH, resulting in outcomes consistent with the labeled claims. The percentage recovery demonstrated the lack of interference from excipients present in the formulations. The proposed method for estimating RGF MH has proven to be specific, simple, precise, rapid, and accurate. Hence, developed method is suitable for monitoring RGF MH drug content in routine analysis within quality control laboratories, applicable to both pure and commercially available dosage forms.

Keywords: UV Spectrophotometer, regorafenib monohydrate, validation, accuracy, precision, ICH.