Capecitabine is a prodrug of 5-fluorouracil, employed as a monotherapy or combination chemotherapy agent for treatment of colorectal cancer. Combination therapy of capecitabine consists of oxaliplatin, and hence, it becomes essential to determine that co-administration does not affect its metabolism. High-performance liquid chromatography and high-performance thin-layer chromatography methods were developed and validated to determine the plasma concentration of capecitabine. In this study, blood samples from 12 patients with colorectal cancer were collected and analyzed by both methods with a reference internal standard. Two groups consisting of six patients each were formed: the first group was treated with capecitabine monotherapy, the second group with capecitabine + oxaliplatin combination therapy. The results of analysis from both the methods indicated that there is no significant drug-drug interaction. The co-administration of oxaliplatin did not affect the metabolism of capecitabine. Both assay methods were compared for their sensitivity, robustness and specificity. It was found that both the assay methods were suitable for therapeutic drug monitoring of capecitabine.

中文翻译：

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HPLC和HPTLC方法开发和验证用于大肠癌患者卡培他滨治疗药物监测的方法。

卡培他滨是5-氟尿嘧啶的前药，用作治疗结直肠癌的单一疗法或联合化疗药物。卡培他滨的联合治疗由奥沙利铂组成，因此，确定共同给药不影响其代谢至关重要。开发并验证了高效液相色谱法和高性能薄层色谱法测定卡培他滨的血浆浓度。在这项研究中，收集了12名结直肠癌患者的血样，并通过两种方法与参考内标进行了分析。分为两组，每组六个患者：第一组接受卡培他滨单药治疗，第二组接受卡培他滨+奥沙利铂联合治疗。两种方法的分析结果均表明没有明显的药物相互作用。奥沙利铂的共同给药不影响卡培他滨的代谢。比较了两种测定方法的敏感性，鲁棒性和特异性。发现两种测定方法均适用于卡培他滨的治疗药物监测。