Abstract

Cancer is one of the major health problems with an increasing incidence and mortality. Although imaging and effective treatment methods are critical issues to prevent cancer mortality, they are inadequate. Therefore, new approaches including combined treatment protocol and nanosized drug delivery theranostic systems are being investigated because of the deficiency of conventional cancer imaging and treatment methods in clinics. Liposomes attract attention in cancer imaging and treatment due to their advantages. In this study, an HPLC method was developed for simultaneous quantification of paclitaxel (PCX) and vinorelbine tartarate (VNB) in co-drug encapsulated theranostic nanosized liposome formulations as an effective cancer imaging and treatment agent. The method was validated according to ICH Analytical Method Validation guideline. According to the validation results, the method was found to be linear (r > 0.999), accurate (bias ≤ 1.8), precise (RSD ≤ 1.8%) and robust (p > 0.05). The developed method was successfully applied to the quantification of PCX and VBN in liposomes for encapsulation efficiency.

中文翻译：

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同时定量包裹在治疗诊断纳米脂质体中的紫杉醇和长春瑞滨

摘要

癌症是主要的健康问题之一，其发病率和死亡率不断增加。尽管成像和有效的治疗方法是预防癌症死亡的关键问题，但它们还不够。因此，由于临床上常规癌症成像和治疗方法的不足，正在研究包括联合治疗方案和纳米药物递送治疗诊断系统在内的新方法。由于其优势，脂质体在癌症成像和治疗中受到关注。在本研究中，开发了一种同时定量紫杉醇 ( PCX ) 和酒石酸长春瑞滨 ( VNB )的 HPLC 方法。) 在共药包封的治疗诊断纳米脂质体制剂中作为有效的癌症成像和治疗剂。该方法根据 ICH 分析方法验证指南进行了验证。根据验证结果，发现该方法线性（r > 0.999）、准确（偏差≤ 1.8）、精确（RSD ≤ 1.8%）和稳健（p > 0.05）。所开发的方法已成功应用于脂质体中 PCX 和 VBN 的定量，以提高封装效率。