New Analytical Method for Simultaneous Analysis of Losartan and E-3174 by HPLC in Human Plasma: Application in Pharmaceutical Science

2020 ◽  
Vol 16 (8) ◽  
pp. 979-987
Author(s):  
Edgar Alejandro de Leon-Diaz de Leon ◽  
Antonio Gordillo-Moscoso ◽  
Úrsula Medina ◽  
Ángel Antonio Vertiz Hernández ◽  
Rafael Almendra-Pegueros ◽  
...  
Keyword(s):  
Human Plasma ◽  
Analytical Method ◽  
Compartmental Model ◽  
Pharmacokinetic Profile ◽  
Therapeutic Drug ◽  
Plasma Samples ◽  
Simultaneous Quantification ◽  
Human Plasma Samples ◽  
Development And Validation

Background: Losartan, one of the most frequently used drugs in Heart Failure (HF) treatment, could be modified for its bioavailability (BA) by generic formulations and other factors. Hence, the importance of therapeutic drug monitoring. Objective: Development and validation of a simplified analytical method using HPLC for simultaneous quantification of losartan and E-3174 in human plasma samples. The method was tested for determining the pharmacokinetics parameters of HF patients. Methods: Analytical conditions were optimized using a C18 column (4.6 X 50 mm, 3 μm. Thermo Scientific) at 25ºC. Conditions of mobile phase: a phosphate buffer (0.01M), adjusted to pH 2.5 with phosphoric acid (1M) and Acetonitrile (60:40 v/v). The flow rate was maintained at 1.2 mL/min, on a running time of 5 min and a sample injection volume of 50 μL. Absorbance for measurement of losartan and E-3174 was 200 nm. Pharmacokinetics profiles were determined with Phoenix Win- Nonlin 8.1 software in a non-compartmental model. Results: Analytical method developed and validated in this work is precise and accurate for simultaneous determination of losartan and E-3174 in human plasma samples in a range of 0.02 -10 μg/mL. In HF subjects, lower Tmax and higher Cmax for losartan and E-3174 patent than generic formulation were observed, which can be translated into less biological effect and more time to present it by the generic drug. Conclusion: The pharmacokinetic profile is dependent on the type of formulation studied (generic/ patent) hence the importance of conducting evaluations in our patients to ensure that the expected therapeutic effect is achieved with treatment administered.

High-throughput identification and determination of aminoglycoside antibiotics in human plasma using UPLC–Q-ToF-MS

2021 ◽  
pp. 146906672110031
Author(s):  
Sawa Minohara ◽  
Masaya Fujishiro ◽  
Xiao-Pen Lee ◽  
Ayumi Imai ◽  
Mari Hashimoto ◽  
...  
Keyword(s):  
Human Plasma ◽  
High Throughput ◽  
Internal Standard ◽  
Aminoglycoside Antibiotics ◽  
Therapeutic Drug ◽  
Regression Equations ◽  
Plasma Samples ◽  
Human Plasma Samples ◽  
Tof Ms

Aminoglycosides are a class of broad-spectrum antibiotics with several clinical uses. Owing to the ototoxicity and nephrotoxicity of aminoglycosides, therapeutic drug monitoring is required. This study aimed to devise a high-throughput method for identification and quantitative determination of aminoglycoside antibiotics in human plasma samples using ultra-performance liquid chromatography–quadrupole time-of-flight-mass spectrometry (UPLC–Q-ToF-MS). Plasma samples (100 µL) spiked with five aminoglycosides (streptomycin, spectinomycin, amikacin, kanamycin, and gentamycin) and an internal standard (ribostamycin) were diluted and centrifuged in aqueous formic acid and acetonitrile. The clear supernatant extract was evaporated and reconstituted in the mobile phase, of which 4 µL was subjected to UPLC–Q-ToF-MS. Prominent peaks were observed for the drugs within 3 min. The recoveries of five aminoglycosides from plasma samples were 92.6–120%. The regression equations showed excellent linearity (0.9999 ≥ r2 ≥ 0.9987) within the range of 1.0–100 µg/mL, and detection limits of 0.5–2.0 µg/mL. The coefficients of the intra- and inter-day variations for five drugs were less than 11.8%, while the accuracy of quantitation was in the range of 89–111%. In this study, a novel method was presented for identification and determination of aminoglycosides in human plasma samples using UPLC–Q-ToF-MS analysis. This method can be applied to high-throughput analysis used for clinical and environmental purposes.

Optimizationvia experimental design of an SPE-HPLC-UV-fluorescence method for the determination of valsartan and its metabolite in human plasma samples

2006 ◽  
Vol 29 (15) ◽  
pp. 2265-2283 ◽  
Author(s):  
Gorka Iriarte ◽  
Nerea Ferreirós ◽  
Izaskun Ibarrondo ◽  
Rosa Maria Alonso ◽  
Miren Itxaso Maguregi ◽  
...  
Keyword(s):  
Experimental Design ◽  
Human Plasma ◽  
Fluorescence Method ◽  
Plasma Samples ◽  
Uv Fluorescence ◽  
Human Plasma Samples

scholarly journals Spectrofluorimetric Determination of Warfarin Sodium by Using N1-Methylnicotinamide Chloride as a Fluorigenic Agent

2005 ◽  
Vol 88 (2) ◽  
pp. 455-461 ◽  
Author(s):  
Mohamed A El Dawy ◽  
Mokhtar M Mabrouk ◽  
Riad A El Barbary
Keyword(s):  
Aqueous Solutions ◽  
Human Plasma ◽  
Plasma Samples ◽  
Spiked Human Plasma ◽  
Human Plasma Samples ◽  
Warfarin Sodium ◽  
Spectrofluorimetric Method ◽  
Spectrofluorimetric Determination ◽  
Methylene Groups

Abstract A spectrofluorimetric method is described for the determination of drugs containing active methylene groups adjacent to carbonyl groups. The method was applied successfully to the determination of warfarin sodium in laboratory-prepared mixtures, in commercial tablets, and in spiked human plasma samples. Finally, the method was applied to the determination of the steady-state concentration of warfarin sodium in the blood of a hospitalized patient. The method involves the reaction of warfarin sodium with 0.2 ml (0.4 × 10−3M) N1-methylnicotinamide chloride reagent in the presence of 3 mL 1.0N NaOH and cooling in ice for 8 min, followed by adjustment of the pH to 2.0, using formic acid and heating for 4 min, whereby a highly fluorescent reaction product is produced. The optimal wavelengths of excitation and emission were determined by using a synchronous wavelength search and found to be 284 and 354 nm, respectively. The standard curves were linear over a concentration range of 50–1500 ng/mL in both aqueous solutions and spiked human plasma samples. The mean recoveries (± standard deviation) were 101.157 (±1.33) and 95.73 (±1.88%) for aqueous solutions and spiked human plasma samples, respectively. The method showed good specificity and precision. The proposed method is simple and economical because of its minimal instrumentation and chemicals requirements. Nevertheless, it is highly sensitive, specific, and reproducible. Accordingly, it is suitable for quality-control applications, drug monitoring, and bioavailability and bioequivalency studies.

Development and validation of a UPLC–MS/MS method for simultaneous determination of LBPT and its metabolites in human plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 211-220
Author(s):  
Mengyi Wu ◽  
Aijing Liu ◽  
Quankun Zhuang ◽  
Ranran Jia ◽  
Yinping Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Plasma ◽  
Tandem Mass ◽  
Plasma Samples ◽  
Triple Quadrupole ◽  
Multiple Reactions ◽  
The Us ◽  
Us Fda ◽  
Development And Validation

Aim: A UPLC–MS/MS method was developed to determine LBPT as well as its four metabolites in human plasma to support the clinical study aiming to evaluate the efficacy of LBPT tablet in patients undergoing hip/knee replacement. Methodology: Plasma samples were prepared by protein precipitation and then separated on a C18 analytical column using (A) acetonitrile (B) 0.1% formic acid and 10 mM ammonium formate in water. The detection was performed on a triple quadrupole tandem mass spectrometer in positive electrospray ionization using multiple reactions monitoring mode. Results & conclusion: The method has been validated in accordance with the US FDA guidelines and was applied to the measurement of five analytes in human plasma samples from a Phase II clinical trial.

Determination of Rivaroxaban in Human Plasma Samples

2012 ◽  
Vol 38 (02) ◽  
pp. 178-184 ◽  
Author(s):  
Job Harenberg ◽  
Sandra Erdle ◽  
Svetlana Marx ◽  
Roland Krämer
Keyword(s):  
Human Plasma ◽  
Plasma Samples ◽  
Human Plasma Samples
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