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Abstract：
Introduction The research aimed to develop a robust, high-performance liquid chromatography (HPLC) analytical method for the quantitative assessment of rebamipide encapsulated in ethosomes. Rebamipide, a quinolinone derivative, holds promise as a therapeutic agent for dry eye, but challenges such as low bioavailability and vision clouding post-installation have prompted innovative approaches. Encapsulation in ethosomes, lipid-based nanovesicles, offers a potential solution to enhance ocular bioavailability. Materials and methods The study focused on creating a specific, linear, accurate, precise, and robust HPLC method, addressing entrapment efficiency (%EE), drug content, and drug release of rebamipide in prepared ethosomes. Statistical validation followed International Conference of Harmonization (ICH) specifications. The method\'s parameters were evaluated within a concentration range of 4-24 µg/ml, with recovery rates indicating accuracy and low % relative standard deviation (RSD) values confirming precision. Limits of detection (LOD) and quantification (LOQ) for rebamipide were determined. Results After preparing the ethosome dosage form by film hydrating method for rebamipide, the rebamipide entrapment efficiency in ethosomes was established at 76% ± 7, while the drug content was found to be 93% ± 6. The drug release process demonstrated zero-order kinetics and five different models of kinetics were applied for a comprehensive analysis. The method exhibited excellent system suitability, specificity, and linearity. Recovery rates for rebamipide ranged from 90% to 100%, and repeatability was confirmed by low %RSD values. The LOD and LOQ for rebamipide were determined to be 1.04 μg/mL and 3.16 μg/mL, respectively. Conclusion The developed HPLC method proved suitable for the quantitative determination of rebamipide in ethosomes, offering rapid and accurate analysis. The results underscore the method\'s specificity, accuracy, and precision within the specified concentration range. Overall, the validated method contributes to the advancement of ocular drug delivery systems, providing a reliable analytical tool for pharmaceutical research.
摘要：
引言这项研究旨在开发一种稳健的，高效液相色谱（HPLC）分析方法，用于定量评估脂质体中包封的瑞巴派特。Rebamipide,喹啉酮衍生物，有望成为干眼症的治疗剂，但是生物利用度低和安装后视力模糊等挑战促使了创新的方法.在乙醇体中封装，基于脂质的纳米囊泡，提供了提高眼部生物利用度的潜在解决方案。材料和方法该研究的重点是创建一个特定的，线性,准确,精确，和强大的HPLC方法，寻址截留效率(%EE)，药物含量,和瑞巴派特在制备的乙醇体中的药物释放。统计验证遵循国际协调会议(ICH)规范。该方法的参数在4-24µg/ml的浓度范围内进行评估，回收率指示准确性和低%相对标准偏差(RSD)值确认精密度。确定了瑞巴派特的检测限(LOD)和定量(LOQ)。结果通过薄膜水合方法制备瑞巴派特的脂质体剂型后，乙醇体中的瑞巴派特包封率为76%±7,而药物含量为93%±6.药物释放过程表现出零级动力学，并应用五种不同的动力学模型进行了综合分析。该方法表现出优异的系统适用性，特异性，和线性。瑞巴派特的回收率在90%到100%之间，低%RSD值证实了重复性。瑞巴派特的LOD和LOQ分别为1.04μg/mL和3.16μg/mL，分别。结论所建立的高效液相色谱法可用于醇质体中瑞巴派特的定量测定。提供快速准确的分析。结果强调了该方法的特异性，准确度,和精度在规定的浓度范围内。总的来说,经过验证的方法有助于眼部给药系统的发展，为药物研究提供可靠的分析工具。
