Analytical Validation of Clopidogrel in Human Plasma Through Ultrahighperformance Liquid Chromatography-Tandem Mass Spectrometry

Harahap, Yahdiana; Maysyarah, Innet

doi:10.22159/ijap.2017.v9s1.79_86

Cited by 5 publications

(3 citation statements)

References 11 publications

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“…The results of REMO stability tests were summarized in table 6. The findings showed that REMO was durable in rat plasma under various storage conditions studied, including stored at Freeze-thaw at-80 °C, Bench top (normal room temperature) for 48 h, Auto-sampler at 2-8 °C for 24 h and Long term at-80 °C for 30 d [24].…”

Section: Stability Studiesmentioning

confidence: 94%

Pharmacokinetic Investigation of Remogliflozin in Rat Plasma Samples by High-Throughput HPLC-MS-MS

2022

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Objective: Remogliflozin (REMO), a selective inhibitor of the renal sodium-dependent glucose transporter 2 channel, which could increase urine glucose excretion and lower plasma glucose in humans. To establish a simple, sensitive and completely validated HPLC-MS-MS approach for the analysis of Remogliflozin in rat plasma samples. Methods: The method was developed after simple step protein precipitation by acetonitrile and Empagliflozin (EMPA) was used as internal standard. Separation was done on an CORTECS C18, 90 Å, 2.7 µm, 4.6 mm X 150 mm with an isocratic mobile phase consisting of 0.1% Formic acid: acetonitrile (20:80%, v/v) and pumped at a flow stream of 0.8 ml/min at ambient temperature. Results: The approach developed showed fine calibration curve in the quantity range of 5-1000 pg/ml with correlation coefficient (r2) of ≥ 0.9997 and the intra-run accuracy and precision was 99.91 to 109.07% and 0.17 to 1.34, inter-run accuracy and precision was 99.8 to 101.54 and 0.17 to 1.66 according to FDA guidelines. Conclusion: The newly designed and validated approach was simple, fast and applied effectively for single-dose oral pharmacokinetic investigation in Wistar male rats for the quantification of REMO in biological matrix.

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Section: Stability Studiesmentioning

confidence: 94%

Pharmacokinetic Investigation of Remogliflozin in Rat Plasma Samples by High-Throughput HPLC-MS-MS

2022

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“…Chromatographic separation is based on the transfer of a liquid (mobile phase) carrying the analytical mixture through a stationary medium. The interaction difference of the analyte with the surface of the medium results in a difference in retention time between the components of the mixture [16][17][18][19][20]. UPLC differs from other chromatographic methods in the size of the column particles is substantially smaller.…”

Section: Chromatography Conditionmentioning

confidence: 99%

The Effect of Anticoagulant Types on the in Vitro Analysis of Clopidogrel in Human Plasma Using Liquid Chromatography Tandem-Mass Spectrometry

2018

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Objective: The aim of this study was to optimize and validate a plasma clopidogrel analysis method using liquid chromatography tandem-mass spectrometry.Methods: Plasma samples were analyzed using a BEH C18 column (1.7 μm; 100 mm×2.1 mm), the mobile phase was 0.1% formic acid in acetonitrile (30:70, v/v). The flow rate was 0.2 mL/min, with a column temperature set to 35°C, an injection volume of 5 μL, an analysis time of 4 min, and irbesartan as the internal standard. Aliquots were obtained by liquid-liquid extraction using ammonium acetate and diethyl ether. The stability and peak area ratio of the respective plasma area responses were evaluated using ANOVA.Results: No significant differences (p>0.05) were observed between anticoagulants regarding analyte stability. However, the peak area ratio showed significant differences (p<0.05) between the anticoagulants. The accuracy and precision of the analysis with citrate, heparin, and ethylenediaminetetraacetic acid (EDTA) plasma met the quality requirements, and a linear calibration curve was created with concentrations ranging from 0.02 to 5.0 ng/mL. Conclusion:The results showed that improved analysis of clopidogrel was achieved using citrate or heparin plasma compared with EDTA plasma.

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“…[21]. The goal of the research was to develop a fast and empathetic bioanalytical HPLC technique for the quantitation of clopidogrel bisulfate I In nt te er rn na at ti io on na al l J Jo ou ur rn na al l o of f A Ap pp pl li ie ed d P Ph ha ar rm ma ac ce eu ut ti ic cs s in plasma samples and the application of ICH regulatory guidelines for method validation.…”

mentioning

confidence: 99%

Bioanalytical Rp-HPLC Method Development and Validation of Clopidogrel Bisulfate in Wistar Rat Plasma and Its Application to Pharmacokinetic Study

2022

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Objective: A novel, simple, precise, accurate, sensitive, and reproducible HPLC method for determining clopidogrel bisulfate in Wistar rat plasma was developed and validated. Methods: The chromatographic separation was performed using Xterra C18 (250 x 4.6 mm, 5μ) column. Mobile phase composed of Acetonitrile ACN: 0.05M potassium dihydrogen orthophosphate buffer pH 4.2 and in the ratio of 75:25% v/v at a flow rate of 1.2 ml/min. Detection was carried out using a PDA detector at 220 nm. The bioanalytical clopidogrel method was validated as per ICH guidelines. Results: The selected chromatographic condition was found to efficiently separate clopidogrel bisulfate (RT-2.838 min). The calibration curve was linear over the concentration range 40-200 ng/ml in Wistar rat plasma with a correlation coefficient of 0.999, respectively. The precision study revealed that the cumulative percentage variation was within the acceptable limit, and accuracy research showed the value of mean percent recovery between 99.72-99.83 %. Conclusion: A simple, rapid, specific, accurate, and precise analytical method was developed and validated using Wistar rat plasma. The technique was strictly validated according to the ICH guidelines. Acquired results demonstrate that the proposed strategy can be effortlessly and advantageously applied for routine analysis of clopidogrel in the Wistar rat plasma.

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Analytical Validation of Clopidogrel in Human Plasma Through Ultrahighperformance Liquid Chromatography-Tandem Mass Spectrometry

Cited by 5 publications

References 11 publications

Pharmacokinetic Investigation of Remogliflozin in Rat Plasma Samples by High-Throughput HPLC-MS-MS

Pharmacokinetic Investigation of Remogliflozin in Rat Plasma Samples by High-Throughput HPLC-MS-MS

The Effect of Anticoagulant Types on the in Vitro Analysis of Clopidogrel in Human Plasma Using Liquid Chromatography Tandem-Mass Spectrometry

Bioanalytical Rp-HPLC Method Development and Validation of Clopidogrel Bisulfate in Wistar Rat Plasma and Its Application to Pharmacokinetic Study

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