New Validated Method for the Estimation of Capecitabine and Docetaxel Using RP-UPLC

Aims: Study on degradation of Capecitabine and Docetaxel based on a new, validated method using UPLC.

Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021.

Methodology: With a flow rate of 1 mL/min and a wave length of 255 nm, the proposed method successfully separated the target metabolite using a Symmetry C18 column (150 mm x 4.6mm,3.5 µm), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) as the mobile phase. The retention times for Capecitabine and Docetaxel were 1.223 minutes and 1.864 minutes, respectively. The isocratic chromatography procedure took about ten minutes to complete at room temperature.

Results: The analysis was completed in three minutes with a concentration range of 5-75 µg/mL capecitabine and 2-30 µg/mL docetaxel that was honest in linearity. The system's suitability parameters were examined mathematically, and the outcomes fell within acceptable ranges. Stages with regression coefficients of 0.999 were used in the linear analysis. Capecitabine's LOD and LOQ concentrations were 1.5 µg/mL and 5 µg/mL, respectively, while Docetaxel was 0.6 µg/mL and 2 µg/mL. 98-102% of the drug was recovered, which means the recovery was within acceptable limits.

Conclusion: The approach was found to be suitable for bulk and formulation analysis after the validation results were satisfactory. According to ICH guidelines, the recommended procedure was found to be justified.