Paclitaxel (PTX) and sulforaphane (SFN) are known anticancer molecules. Their activity was found to be potentiated when tested concurrently. Only recently, however, a novel SFN enabled PTX self-microemulsifying formulation (SMEDDS) was developed for their simultaneous delivery. This necessitated the development of an analytical method for the simultaneous detection and quantitation of PTX and SFN. In this study, a simple and sensitive isocratic high performance liquid chromatography-ultraviolet (HPLC-UV) analytical method was developed and validated per International Conference on Harmonization guidelines to satisfy this objective. Its application was demonstrated when quantifying the amount of PTX and SFN released from the SMEDDS in various dissolution media. The separation of the analytes was performed with the aid of a reversed phase C18 column at ambient temperature using a 60:40 mixture of acetonitrile and KH2PO4 buffer (pH 5.0) as the mobile phase. PTX and SFN peaks were detected at 202 nm with high resolution without interference from excipients. This method showed linearity within 2.5-100 μg/mL range with r2 > 0.999. The limit of detection and lower limit of quantitation were 0.1638 and 0.4964 μg/mL for PTX and 0.4419 and 1.3389 μg/mL for SFN, respectively. A total of 98-101% of the injected samples was recovered with RSD of 0.06-0.68% indicating the suitability of the method for the simultaneous detection and quantitation of the molecules in dissolution media.

中文翻译：

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HPLC-UV方法的开发和验证，用于同时检测和定量脂质自微乳化制剂中的紫杉醇和萝卜硫素。

紫杉醇（PTX）和萝卜硫烷（SFN）是已知的抗癌分子。并发测试发现它们的活性增强。然而，直到最近，才开发出一种新型的具有SFN功能的PTX自微乳化制剂（SMEDDS），用于其同时交付。这就需要开发一种用于同时检测和定量PTX和SFN的分析方法。在这项研究中，开发了一种简单而灵敏的等度高效液相色谱-紫外（HPLC-UV）分析方法，并根据国际协调会议指南进行了验证，以实现此目标。当定量从各种溶解介质中从SMEDDS释放的PTX和SFN的量时，证明了其应用。在室温下，使用反相C18色谱柱，使用乙腈和KH2PO4缓冲液（pH 5.0）的60:40混合物作为流动相，进行分析物的分离。在202 nm处以高分辨率检测到PTX和SFN峰，而没有受到赋形剂的干扰。该方法显示线性在2.5-100μg/ mL范围内，r2> 0.999。PTX的检出限和定量下限分别为0.1638和0.4964μg/ mL，SFN的分别为0.4419和1.3389μg/ mL。回收的注射样品总量为98-101％，RSD为0.06-0.68％，表明该方法适用于同时检测和定量溶解介质中的分子。在202 nm处以高分辨率检测到PTX和SFN峰，而没有受到赋形剂的干扰。该方法显示线性在2.5-100μg/ mL范围内，r2> 0.999。PTX的检出限和定量下限分别为0.1638和0.4964μg/ mL，SFN的分别为0.4419和1.3389μg/ mL。回收的注射样品总量为98-101％，RSD为0.06-0.68％，表明该方法适用于同时检测和定量溶解介质中的分子。在202 nm处以高分辨率检测到PTX和SFN峰，而没有受到赋形剂的干扰。该方法显示线性在2.5-100μg/ mL范围内，r2> 0.999。PTX的检出限和定量下限分别为0.1638和0.4964μg/ mL，SFN的分别为0.4419和1.3389μg/ mL。回收的注射样品总量为98-101％，RSD为0.06-0.68％，表明该方法适用于同时检测和定量溶解介质中的分子。