Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC

European Pharmaceutical Journal Pub Date : 2021-12-01 DOI:10.2478/afpuc-2021-0019

R. Kachave, A. G. Mundhe

{"title":"Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC","authors":"R. Kachave, A. G. Mundhe","doi":"10.2478/afpuc-2021-0019","DOIUrl":null,"url":null,"abstract":"Abstract Aim Nebivolol and valsartan are used in the treatment of hypertension. So, this study was conducted for the purpose of determining bioavailability/bioequivalence of nebivolol and valsartan in human plasma. Materials and Methods The chromatographic separation was performed on Symmetry C18 (150 × 4.6 mm, 5 μm) column using 0.01 N potassium dihydrogen phosphate (pH 3.0):acetonitrile (60:40) as the mobile phase at a flow rate of 1.0 mL/min and a detector wavelength of 280 nm. The retention times of nebivolol and valsartan in plasma were found to be 3.1 and 4.3 min, respectively. Results The method was validated statistically and by recovery studies. The linearity concentration was acceptable in the range of 0.5–10 ng/mL for nebivolol and 400–8000 ng/mL for valsartan. The lower limits of quantification were 0.5 ng/mL for nebivolol and 400 ng/mL for valsartan, which reached the levels of both drugs possibly found in human plasma. Per cent recoveries were obtained as 97.78% and 98.11% for nebivolol and valsartan, respectively. Conclusion The proposed method is simple, rapid, accurate, precise and gives us knowledge about the pharmacokinetics and therapeutic drug monitoring in clinical laboratories.","PeriodicalId":12070,"journal":{"name":"European Pharmaceutical Journal","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Pharmaceutical Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2478/afpuc-2021-0019","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 1

Abstract

Abstract Aim Nebivolol and valsartan are used in the treatment of hypertension. So, this study was conducted for the purpose of determining bioavailability/bioequivalence of nebivolol and valsartan in human plasma. Materials and Methods The chromatographic separation was performed on Symmetry C18 (150 × 4.6 mm, 5 μm) column using 0.01 N potassium dihydrogen phosphate (pH 3.0):acetonitrile (60:40) as the mobile phase at a flow rate of 1.0 mL/min and a detector wavelength of 280 nm. The retention times of nebivolol and valsartan in plasma were found to be 3.1 and 4.3 min, respectively. Results The method was validated statistically and by recovery studies. The linearity concentration was acceptable in the range of 0.5–10 ng/mL for nebivolol and 400–8000 ng/mL for valsartan. The lower limits of quantification were 0.5 ng/mL for nebivolol and 400 ng/mL for valsartan, which reached the levels of both drugs possibly found in human plasma. Per cent recoveries were obtained as 97.78% and 98.11% for nebivolol and valsartan, respectively. Conclusion The proposed method is simple, rapid, accurate, precise and gives us knowledge about the pharmacokinetics and therapeutic drug monitoring in clinical laboratories.

查看原文本刊更多论文

反相高效液相色谱法测定人血浆中奈比洛尔和缬沙坦的方法建立及验证

摘要目的应用奈比洛尔和缬沙坦治疗高血压。因此，本研究旨在测定奈比洛尔和缬沙坦在人体血浆中的生物利用度/生物等效性。材料与方法色谱分离采用对称C18（150×4.6mm，5μm）柱，流动相为0.01N磷酸二氢钾（pH3.0）：乙腈（60:40），流速1.0mL/min，检测波长280nm。奈比洛尔和缬沙坦在血浆中的保留时间分别为3.1和4.3分钟。结果该方法经统计学和回收率研究验证。奈比洛尔和缬沙坦的线性浓度在0.5–10 ng/mL和400–8000 ng/mL范围内是可接受的。奈比洛尔和缬沙坦的定量下限分别为0.5 ng/mL和400 ng/mL，达到了可能在人类血浆中发现的两种药物的水平。奈比洛尔和缬沙坦的回收率分别为97.78%和98.11%。结论该方法简便、快速、准确、准确，为临床实验室药物动力学和治疗药物监测提供了依据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

0.60

自引率

0.00%

发文量

期刊介绍： European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.