利用 RP-HPLC 和液相萃取技术开发和验证人血浆中利伐沙班的生物分析方法及其在生物等效性研究中的应用

Q3 Pharmacology, Toxicology and Pharmaceutics

Research Journal of Pharmacy and Technology Pub Date : 2024-02-20 DOI:10.52711/0974-360x.2024.00115

Saurav R. Dunbale, Deelip V. Derle, Ashlesha A. Wakchaure, Ashwini A. Amrutkar, Amol V. More

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引用次数: 0

摘要

利伐沙班是一种直接作用的口服抗凝剂和 Xa 因子抑制剂。本研究建立并验证了一种简便、选择性强、精确、快速的 RP-HPLC 方法来估测人血浆中的利伐沙班（RIVA）。血浆中的样品加标采用液相萃取法提取，有机溶剂为乙酸乙酯。阿哌沙班作为内标。采用安捷伦高效液相色谱仪和控制面板软件，在 Inertsil ODS（250 毫米 x 4.6 毫米内径；5 微米）色谱柱上使用紫外检测器对化合物进行分析，流速为 1.2 毫升/分钟，等度流动相为 0.02M 乙酸铵缓冲液：乙腈（70:30%v/v）组成的等度流动相。对不同的样品前处理技术进行了评估，发现液液萃取效果令人满意，RIVA 的回收率高达 93.70%。所开发的方法通过了 ICHM10 和 USFDA 指南的验证，在人体血浆中的浓度范围为 5.00 至 200.00 ng/ml，R² =0.9993。RIVA的日内精密度和准确度分别为0.36%至4.73%和92.58%至101.82%。经过验证的 RP-HPLC 方法已成功用于初步药代动力学研究和治疗药物监测。

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Development and Validation of Bioanalytical Method for Estimation of Rivaroxaban using RP-HPLC with Liquid liquid extraction in Human Blood Plasma and its application in Bioequivalence Study

Rivaroxaban is andirect acting oralanticoagulant and factor Xa inhibitor. A simple, selective, precise and rapid RP-HPLC method for estimation of Rivaroxaban (RIVA) in human blood plasma was developed and validated. The sample spike in plasma was extracted using liquid liquid extraction were extracted with the organic solvent ethyl acetate as organic solvent. Apixaban as an internal standard. The compounds were analysed by Agilent HPLC was used with control panel software using UV detector on a Inertsil ODS (250mm x 4.6mm ID;5μ) column with an Flow rate of 1.2mL/min, an isocratic mobile phase consisting of 0.02M Ammonium acetate buffer: Acetonitrile (70:30%v/v). Different sample pre-treatment techniques were evaluated, but Liquid Liquid extraction was found to be satisfactory, with good recovery values of 93.70% for RIVA. The developed method is validated by ICHM10 and USFDA guidelines over the concentration range of 5.00 to 200.00 ng/ml in human blood plasma with R² =0.9993. Within-day precisions and accuracy for RIVA were found in 0.36% to 4.73% and 92.58% to101.82% respectively. The validated RP-HPLC method has been used successfully for both preliminary pharmacokinetic studies and therapeutic drug monitoring

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来源期刊

Research Journal of Pharmacy and Technology Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

1.40

自引率

0.00%

发文量

期刊介绍： Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal, devoted to pharmaceutical sciences. The aim of RJPT is to increase the impact of pharmaceutical research both in academia and industry, with strong emphasis on quality and originality. RJPT publishes Original Research Articles, Short Communications, Review Articles in all areas of pharmaceutical sciences from the discovery of a drug up to clinical evaluation. Topics covered are: Pharmaceutics and Pharmacokinetics; Pharmaceutical chemistry including medicinal and analytical chemistry; Pharmacognosy including herbal products standardization and Phytochemistry; Pharmacology: Allied sciences including drug regulatory affairs, Pharmaceutical Marketing, Pharmaceutical Microbiology, Pharmaceutical biochemistry, Pharmaceutical Education and Hospital Pharmacy.