Determination of a Macromolecular Prodrug in Bulk and Microsphere Formulation by High Performance Thin Layer Chromatography

IF 1 4区化学 Q4 CHEMISTRY, ANALYTICAL Journal of Analytical Chemistry Pub Date : 2024-06-21 DOI:10.1134/s1061934824700199

Sakshi Shinde, Tejaswani Shinde, Gajanan Shelke, Trupti Kachave, Shakuntala Chopade

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Abstract

Mycophenolic acid is a secondary metabolite of Penicillium brevicompactum and has been extensively studied for its antineoplastic, immunosuppressive, anti-inflammatory, antiviral, antipsoriasis, and antifungal activities. In the present study, a high-performance thin-layer chromatography method was developed for determining mycophenolic acid and a chitosan-linked prodrug using 60 F₂₅₄ silica gel plates. The mobile phase used was chloroform–methanol–water (9.2 : 0.7 : 0.1, v/v/v), which provided good separation. The linearity was found to be in the range of 4–12 µg/spot with an R² value of 0.9973. The percentage of RSD for intra-day and inter-day precision was found to be in the range of 0.7–1.1 and 0.9–2.0, respectively. The limit of detection and limit of quantification of the prodrug were determined to be 0.27 and 0.82 µg/spot, respectively. The recovery of the prodrug obtained was found to be 99.79%, suggesting that the method is simple, accurate, and reproducible. The proposed method proved to be sensitive, accurate, precise, economical, and less time-consuming, making it suitable for successful analysis in microsphere formulations.

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用高效薄层色谱法测定散装和微球配方中的大分子原药

摘要霉酚酸是青霉的次级代谢产物，其抗肿瘤、免疫抑制、抗炎、抗病毒、抗银屑病和抗真菌活性已被广泛研究。本研究采用 60 F254 硅胶板，建立了测定霉酚酸和壳聚糖连接原药的高效薄层色谱法。流动相为氯仿-甲醇-水（9.2 : 0.7 : 0.1, v/v/v），分离效果良好。线性范围为 4-12 µg/spot，R2 值为 0.9973。日内和日间精密度的 RSD 百分比分别为 0.7-1.1 和 0.9-2.0。原药的检出限和定量限分别为 0.27 微克/点和 0.82 微克/点。原药的回收率为 99.79%，表明该方法简便、准确、重现性好。该方法灵敏、准确、精确、经济且耗时少，适用于微球制剂的成功分析。

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来源期刊

Journal of Analytical Chemistry 化学-分析化学

CiteScore

2.10

自引率

9.10%

发文量

146

审稿时长

13 months

期刊介绍： The Journal of Analytical Chemistry is an international peer reviewed journal that covers theoretical and applied aspects of analytical chemistry; it informs the reader about new achievements in analytical methods, instruments and reagents. Ample space is devoted to problems arising in the analysis of vital media such as water and air. Consideration is given to the detection and determination of metal ions, anions, and various organic substances. The journal welcomes manuscripts from all countries in the English or Russian language.