Exploring the potential of a quick and simultaneous DoE-based stability indicating novel RP-HPLC method for the estimation of capecitabine and curcumin in biodegradable nanoparticles and human plasma

Abstract

There is solid evidence that capecitabine (CAP) and curcumin (CUR) can alleviate symptoms of a wide range of illnesses. A fast and specific RP-HPLC method was designed and validated according to ICH requirements, employing an isosbestic point. This technology was chosen for its drug delivery application and synergistic effects of CAP and CUR as no HPLC approach has been documented to estimate and quantify both medicines simultaneously. The mobile phase used for the chromatographic separation was methanol: 0.1 % orthophosphoric acid, (80:20) and the conditions were 1 mL/min flow rate and 332 nm. Shim-pack Solar C18 (4.6 × 250 mm, 5 μm) HPLC column was used for this purpose. With a correlation coefficient value >0.999, the created technique was determined to be linear across the concentration range of 0.25–16 μg/mL. The approach that was created was strong, accurate (with a recovery rate of 91.85–106.53 %), and precise (with a relative standard deviation of <2.0 %). For CAP, the corresponding limits of detection and quantification were determined to be 0.02 and 0.08 μg/mL, whereas for CUR, they were 0.08 and 0.12 μg/mL, respectively. By ICH standards, the proposed approach was also tested in human plasma for validation. In addition, tests were conducted on the stress degradation and the established method's applicability to biodegradable nanoformulation. In the presence of degradation products, there was a good separation of drug peaks. The experimental model was shown to be significant (P < 0.05) after a deliberate adjustment was assessed using analysis of variance. The Quality by Design methodology led to a more accurate procedure that produces consistent, reliable, high-quality data and accurately quantifies CAP and CUR in bulk and nanoparticulate systems.