scholarly journals Bioanalytical Method Development Using Liquid Chromatography with Amperometric Detection for the Pharmacokinetic Evaluation of Forsythiaside in Rats

Molecules ◽  
2016 ◽  
Vol 21 (10) ◽  
pp. 1384 ◽  
Author(s):  
Yu-Tse Wu ◽  
Meng-Ting Cai ◽  
Chih-Wei Chang ◽  
Ching-Chi Yen ◽  
Mei-Chich Hsu
Keyword(s):  
Liquid Chromatography ◽  
Method Development ◽  
Amperometric Detection ◽  
Bioanalytical Method ◽  
Pharmacokinetic Evaluation

scholarly journals A SIMPLE AND RUGGED BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BRIVUDINE IN HUMAN PLASMA BY USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 45-50
Author(s):  
S. SATHESHKUMAR ◽  
V. MURUGANANTHAM
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Limit Of Detection ◽  
Research Work ◽  
Bioanalytical Method ◽  
Method Development And Validation ◽  
Development And Validation

Objective: The current research work focus to simple and rugged bioanalytical method development and validation of brivudine in human plasma using high-performance liquid chromatography. Methods: The analyte (Brivudine) and internal standard (Sofosbuvir) were extracted using the Solid Phase Extraction (SPE) technique. The chromatographic separation was accomplished by using Zorbax eclipse XDB-C18 Column (150×4.6 mm, 5 μm) with a mobile phase consisted of Methanol: 0.5% Ortho-phosphoric acid (65:35%, v/v) respectively, at a flow rate of 0.7 mL/min. The developed method was validated by performing system suitability, carryover effect, linearity, selectivity, sensitivity, precision, accuracy, recovery, ruggedness, and stability studies. The method was validated as per USFDA guidelines. Results: The selected chromatographic condition was found to efficiently separated brivudine (RT-3.55 min) and ISTD (RT-7.87 min). The assay demonstrated a linear dynamic range of 85.205 to 4500.246 ng/ml for brivudine in human plasma with r2>0.99. Demonstrated the lowest limit of detection at 85.205 ng/ml. This method established an intra-run and inter-run precision within the range of 2.99-6.31%CV and 3.67-5.80%CV, respectively. Additional intra-run and inter-run accuracy were within the range of 97.55-105.37% and 99.27-102.15%, respectively. The mean percentage recovery of brivudine and ISTD studies proved good extraction efficiency and the robustness was also evaluated. Conclusion: A simple, accurate, precise, linear and rugged RP-HPLC method was developed and validated for the estimation of brivudine in human plasma with K2EDTA anticoagulant and suitable for conducting BA/BE and TDM.

scholarly journals A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

2016 ◽  
Vol 9 (9) ◽  
pp. 6 ◽  
Author(s):  
Lokesh Khushalrao Tijare ◽  
Rangari Nt ◽  
Mahajan Un
Keyword(s):  
Liquid Chromatography ◽  
Method Development ◽  
Quantitative Estimation ◽  
Review Article ◽  
Bioanalytical Method ◽  
Large Molecules ◽  
The Matrix ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Nonclinical Study

ABSTRACTIn this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should beapplied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and theirmetabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokineticstudies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigatedto decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of setup to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double massspectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographicmethods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy,precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposedto add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug,concentration and its metabolite.Keywords: Method development, Clinical and nonclinical study, Analyte, Validation of bioanlysis techniques, Validation parameter.

scholarly journals Bioanalytical Method Development and Validation Study of Neuroprotective Extract of Kashmiri Saffron Using Ultra-Fast Liquid Chromatography-Tandem Mass Spectrometry (UFLC-MS/MS): In Vivo Pharmacokinetics of Apocarotenoids and Carotenoids

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1815
Author(s):  
Aboli Girme ◽  
Sandeep Pawar ◽  
Chetana Ghule ◽  
Sushant Shengule ◽  
Ganesh Saste ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Tandem Mass Spectrometry ◽  
Method Development ◽  
Crocus Sativus ◽  
Pharmacokinetic Parameters ◽  
Tandem Mass ◽  
Bioanalytical Method ◽  
Fast Liquid Chromatography

Kashmir saffron (Crocus sativus L.), also known as Indian saffron, is an important Asian medicinal plant with protective therapeutic applications in brain health. The main bioactive in Kashmir or Indian Saffron (KCS) and its extract (CSE) are apocarotenoids picrocrocin (PIC) and safranal (SAF) with carotenoids, crocetin esters (crocins), and crocetins. The ultra-fast liquid chromatography(UFLC)- photodiode array standardization confirmed the presence of biomarkers PIC, trans-4-GG-crocin (T4C), trans-3-Gg-crocin (T3C), cis-4-GG-crocin (C4C), trans-2-gg-crocin (T2C), trans-crocetin (TCT), and SAF in CSE. This study’s objectives were to develop and validate a sensitive and rapid UFLC-tandem mass spectrometry method for PIC and SAF along T4C and TCT in rat plasma with internal standards (IS). The calibration curves were linear (R2 > 0.990), with the lower limit of quantification (LLOQ) as 10 ng/mL. The UFLC-MS/MS assay-based precision (RSD, <15%) and accuracy (RE, −11.03–9.96) on analytical quality control (QC) levels were well within the acceptance criteria with excellent recoveries (91.18–106.86%) in plasma samples. The method was applied to investigate the in vivo pharmacokinetic parameters after oral administration of 40 mg/kg CSE in the rats (n = 6). The active metabolite TCT and T4C, PIC, SAF were quantified for the first time with T3C, C4C, T2C by this validated bioanalytical method, which will be useful for preclinical/clinical trials of CSE as a potential neuroprotective dietary supplement.

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