DEVELOPMENT AND VALIDATION OF A GREEN LIQUID CHROMATOGRAPHICDIODE ARRAY DETECTION METHOD FOR SIMULTANEOUS QUANTIFICATION OF CAPECITABINE AND LAPATINIB IN PHARMACEUTICALS USING ANALYTICAL PROCEDURE DEVELOPMENT CONCEPT

Abstract

Capecitabine and lapatinib are two potent anti-breast cancer drugs used in combination for better therapeutic effects. The current study aims to develop a robust liquid chromatographic method to quantify capecitabine and lapatinib using the concept of analytical procedure development. Risk assessment earmarked critical method variables, and their effect on critical analytical attributes was investigated using a Box-Behnken design. The optimized chromatographic conditions use acetonitrile: 10 mMol L-1 phosphate buffer of pH 3.11 (60:40 V/V) as the mobile phase. The separation was achieved on a C-18 column (250 mm × 4.6 mm, 5 µm), and the mobile phase flow was 0.9 mL min-1 with a diode array detection at 310 nm. The developed method was specific, linear (2 - 64 µg mL-1), accurate (> 99 %), precise (RSD < 1 %), sensitive and selective (recovery > 100 %) for quantification of the said drugs from dosage forms and biological fluids. Employing the analytical eco-scale approach revealed excellent method greenness for routine quantification of capecitabine and lapatinib in various samples.