Investigation of a Quantitative Bioanalytical HPLC Method for the Assessment of Famotidine in Pre-clinical Samples: Application for Pharmacokinetic Studies

Swati Bharati, Vinod L. Gaikwad, Bothiraja Chellampillai
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Abstract

Abstract Famotidine (FAM), a histamine H2 receptor antagonist, is effective against peptic ulcers and Zollinger Ellison syndrome. In the current investigation, a HPLC approach was developed to detect the Famotidine (FAM) in pre-clinical samples (rat plasma). To get rid of any chromatographic solvent effects, methanolic extraction method was used to prepare biological samples. A C18 column was used for chromatographic separation, with a pH-adjusted to 8 as mobile phase of water, methanol, and acetonitrile (70: 20: 10, v/v/v) at a flow rate of 1 mL/min and UV detection at 264 nm. The retention times of FAM was found to be 5.7 min. The technique was linear in the range of 50 to 1400 ng/mL in plasma concentration with R2 of 0.9985. The newly proposed method’s respective limits for quantification and detection were found to be 151.45 ± 6.47 ng/mL and 49.97 ± 2.14 ng/mL. The average recovery rates were discovered to range from 98.06 to 103.56%. After numerous freeze-thaw cycles of the treated plasma samples, analyte was stable and showed no sign of significant deterioration. After a single oral dose of 10 mg/kg of FAM, the approach was effectively used to assess the pharmacokinetic characteristics in Wistar albino rats. Consequently, the straightforward technique would enable quick with affordable detection of the FAM from biological samples. GRAPHICAL ABSTRACT
法莫替丁在临床前样品中的定量生物分析高效液相色谱方法研究:在药代动力学研究中的应用
法莫替丁(FAM)是一种组胺H2受体拮抗剂,对消化性溃疡和佐林格-埃里森综合征有效。本研究建立了一种高效液相色谱法检测临床前样品(大鼠血浆)中的法莫替丁(FAM)。为消除色谱溶剂的影响,采用甲醇萃取法制备生物样品。采用C18色谱柱进行色谱分离,流动相为水、甲醇、乙腈(70∶20∶10,v/v/v), ph调至8,流速为1 mL/min,紫外检测波长为264 nm。FAM的保留时间为5.7 min,在50 ~ 1400 ng/mL血浆浓度范围内呈线性关系,R2为0.9985。方法的定量限和检测限分别为151.45±6.47 ng/mL和49.97±2.14 ng/mL。平均回收率为98.06 ~ 103.56%。经过多次冻融循环处理后的血浆样品,分析物是稳定的,没有显着恶化的迹象。在单次口服10 mg/kg FAM后,该方法有效地评估了Wistar白化大鼠的药代动力学特征。因此,直接的技术将能够快速和负担得起的检测FAM从生物样品。图形抽象
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CiteScore
2.30
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