QbD 辅助分析方法在开发的纳米结构中同时检测四氢姜黄素和叶酸的适用性

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-04-15 DOI:10.2174/0115734110297757240317065850

Parina Kumari, Sarwar Beg, Kamalinder K Singh, Vandita Kakkar

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引用次数: 0

摘要

目的在开发的纳米结构中同时检测四氢姜黄素和叶酸的 QbD 辅助分析方法的适用性：背景：背景：糖尿病足溃疡（DFU）是一种多因素疾病，涉及慢性炎症、氧化应激和神经病变。目前的治疗方法包括使用生长因子和皮肤替代品，但这些方法成本高昂，大多数患者无法负担。本研究探讨了（5929IN008，申请号：202211045937）四氢姜黄素和叶酸组合纳米结构脂质载体的实用性。背景：：糖尿病足溃疡（DFU）是一种多因素疾病，涉及慢性炎症、氧化应激和神经病变。目前的治疗方法包括使用生长因子和皮肤替代品，但由于成本高昂，大多数患者无法负担。本研究探讨了四氢姜黄素和叶酸组合的纳米结构脂质载体（5929IN008，申请号 202211045937）的实用性。目标：：开发并验证同时分析四氢姜黄素（THC）和叶酸（FA）的 QbD 辅助方法。上述方法是否适用于测定负载四氢姜黄素和叶酸的纳米结构脂质载体（NLCs）的总药物含量（TDC）和包埋效率（EE）。方法：：采用方框-贝肯设计法开发、优化和验证了高效液相色谱（HPLC）方法，以提高方法的性能。色谱分离采用 Supelco 250 x 4.6 mm (5 μm)色谱柱，优化流动相组成为四氢呋喃：柠檬酸缓冲液 pH 3.5 (50:50)，流速为 0.4 mL.min-1，二极管阵列检测波长为 210 至 360 nm。结果该方法的线性（R2 0.999，p≤0.001）、准确度（99.10%-101.70%）和精密度高，日内和日间结果的回收率高，浓度范围为 1-100 μg.mL-1。系统适应性和稳健性评价表明，回收率在96.90%至102.80%之间，相对标准偏差（%RSD）小于2%。此外，该方法还可进一步用于 THC 和 FA 的 TDC 测定（86±6% 和 96±8%）和药物 EE 测定（81±21% 和 73±13%）。结论该研究表明，所开发和验证的方法适用于所开发的纳米结构脂质载体中四氢大麻酚和FA的测定。

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Applicability of QbD-assisted Analytical Method for Simultaneous Detection of Tetrahydrocurcumin and Folic Acid in Developed Nanostructured

Aims:: Applicability of QbD-assisted analytical method for simultaneous detection of tetrahydrocurcumin and folic acid in developed nanostructured. background: Background: Diabetic foot ulcer (DFU), a multifactorial disorder involves chronic inflammation, oxidative stress and neuropathy. Current treatment therapies, involving the use of growth factors and skin substitutes being costly, are out of reach for the majority of patients. The present research explored the usefulness of (5929IN008, application number 202211045937) a combination of tetrahydrocurcumin and folic acid loaded nanostructured lipidic carriers. Background:: Diabetic foot ulcer (DFU) is a multifactorial disorder that involves chronic inflammation, oxidative stress and neuropathy. Current treatment therapies involving the use of growth factors and skin substitutes being costly, are out of reach for the majority of patients. The present research explored the usefulness of (5929IN008, application number 202211045937), a combination of tetrahydrocurcumin and folic acid-loaded nanostructured lipidic carriers. Objectives:: To develop and validate a QbD-assisted method for simultaneous analysis of tetrahydrocurcumin (THC) and folic acid (FA). Applicability of the above method to determine total drug content (TDC) and entrapment efficiency (EE) of nanostructured lipid carriers (NLCs) loaded THC and FA. Methods:: A high-performance liquid chromatographic (HPLC) method was developed, optimized and validated using Box-Behnken design for improved method performance. Chromatographic separation was conducted on a Supelco 250 x 4.6 mm (5 μm) column with optimized mobile phase composition containing tetrahydrofuran: citric acid buffer pH 3.5 (50:50) at a flow rate of 0.4 mL.min-1 and diode array detection between 210 and 360 nm. Results:: The method developed in a concentration range of 1 to 100 μg.mL-1 was found to be linear (R2 0.999, p≤0.001), accurate (99.10-101.70%) and precise with high recovery values in intra and inter-day results. The system adaptability and robustness evaluation revealed that the percent recovery ranged from 96.90 to 102.80%, and the percent relative standard deviation (%RSD) values were less than 2%. Moreover, the method was further applied for the determination of TDC (86±6% and 96±8%) and drug EE (81±21% and 73±13%) for THC and FA, respectively. Conclusion:: The investigation indicated the applicability of the developed and validated method for the estimation of THC and FA in the developed nanostructured lipidic carriers.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.