A new chemometrically optimised HPLC method for the simultaneous determination of imatinib mesylate and capecitabine, the active medicinal components

Abstract

ABSTRACT Anticancer drugs such as imatinib mesylate (IMP) and capecitabine (CAP) and their metabolites enter the water cycle through wastewater treatment plant effluents or directly into the water cycle due to their limited biodegradability in typical wastewater treatment plants. However, their long-term effects on water resources are unknown due to their toxicity. The hazards concerned with chronic exposure to these substances raise concerns about their impact on organisms, environmental safety and biodiversity conservation. Therefore, in this study, a chemometrically optimised HPLC method was developed for the simultaneous determination of trace amounts of cytotoxic agents IMP and CAP used in cancer treatment in environmental water, synthetic urine samples and drug samples. Using the Box-Behnken design, optimum conditions discovered using the traditional method were optimised. The effect of each element was evaluated in the design by four factors based on HPLC determination. For the examined levels, mobile phase 1, mobile phase 2 ratio, flow rate, and column temperature parameters for the HPLC method were determined. Using regression analysis on the experimental results, the factors influencing resolution were identified. To achieve the reliability of the results, the Analysis of Variance (ANOVA) test was used. The ANOVA test was employed to verify the consistency of the data. With the information gathered, a model was developed. HPLC was used to examine the target chemicals. A good linearity (R2 > 0.99) was established for the IMP and CAP in the concentration ranges of 1.18–23.59 µg mL−1 and 0.76–15.09 µg mL−1, respectively, under optimum circumstances. The recoveries for spiked samples at three concentration levels ranged from 98.31 to 101.11. The created method has been applied to synthetic urine samples, regional environmental water samples, and pharmaceutical samples with success.