Validation of HPLC Method for the Determination of Mycophenolic Acid in Human Plasma Obtained From Renal Transplant Recipients

Džodić, Predrag; Veličković‐Radovanović, Radmila; Šmelcerović, Andrija; Catić‐Đorđević, Aleksandra; Stefanović, Nikola; Spasić, Ana; Ilić, Dušan; Zivanovic, Svetlana; Ilijev, Ivajlo

doi:10.5633/amm.2016.0404

Cited by 4 publications

(21 citation statements)

References 15 publications

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“…Internal standard methylparaben (IS), as solid standard compound, was purchased from Sigma-Aldrich (Steinheim, Germany). Methanol gradient grade for liquid chromatography was purchased from Avantor Performance Materials (Deventer, The Netherlands) [14]. Trifluoroacetic acid (TFA) for high-performance liquid chromatography (HPLC) was purchased from Fisher Chemical (Loughborough, UK).…”

Section: Experimental Drugs and Materialsmentioning

confidence: 99%

“…The mobile phase was de-gassed and purified by vacuum filtration through 0.45 μm regenerated cellulose membrane filters (Agilent, Böblingen, Germany). Zorbax SB-C18 analytical column (150 mm x 4.6 mm i.d., particle size 3.5 µm) (Agilent, USA) was used for compounds separation [14]. Data were collected using Agilent's ChemStation software.…”

Section: Apparatusmentioning

confidence: 99%

“…Data were collected using Agilent's ChemStation software. The Microsoft Excel software was used for statistical processing [14].…”

Section: Apparatusmentioning

confidence: 99%

“…Ethical approval for this work was obtained from the Ethics Committee (Ethics Committee of Faculty of Medicine, University of Niš, Serbia; approval number 12-519/3) [14]. The investigations followed the international guidelines, WMA Declaration of Helsinki [15].…”

Section: Human Serum Samplesmentioning

confidence: 99%

“…Blank serum was obtained from ten different healthy volunteers (Clinical Centre Niš, Niš, Serbia). Whole blood was taken by means of venipuncture into vacutainers and, after coagulation, separated by centrifugation at 3000 g for 15 min [14]. All serum samples were stored at -20°C until analysis [14].…”

Section: Human Serum Samplesmentioning

confidence: 99%

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A reliable chromatographic method for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum

Džodić¹,

Veličković‐Radovanović²,

Koraćević³

et al. 2020

Trop. J. Pharm Res

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Purpose: To develop and validate a simple chromatographic method for the analysis of ciprofloxacin and moxifloxacin in human serum.Methods: After protein precipitation had been performed, high performance liquid chromatography (HPLC) with UV detection was utilized for the analysis of ciprofloxacin and moxifloxacin in human serum. Analytical column Zorbax SB-C18 (150 mm x 4.6 mm i.d., particle size 3.5 μm) was used as a stationary phase. Chromatographic separation was realized with the mobile phase 0.1% trifluoroacetic acid in water for chromatography - methanol (66:34, v/v), at the flow rate of 1 mL/min, temperature of 35 oC and detection at 280 nm. The method validation was performed according to the guidelines of the European Medicines Agency (EMA).Results: The chromatographic run time was about 12 minutes and no interference was observed. For ciprofloxacin, the method was linear over a concentration range of 0.5-50 μg/mL, with a correlation coefficient of 0.9874. For moxifloxacin, the method was linear over a concentration range of 0.5-50 μg/mL, with a correlation coefficient of 0.9946. Since relative standard deviation (RSD) and relative recovery values were within acceptable limits according to EMA guidelines, good intra-day precision, inter-day precision, as well as the accuracy of the method, were observed.Conclusion: A simple and reliable HPLC-UV method has been developed and validated for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum. The method can be applied for therapeutic drug monitoring but also and pharmacokinetic studies of ciprofloxacin and moxifloxacin. Keywords: Human serum, Ciprofloxacin, Moxifloxacin, Protein precipitation, HPLC, UV detection, Method validation

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Section: Experimental Drugs and Materialsmentioning

confidence: 99%

Section: Apparatusmentioning

confidence: 99%

“…Data were collected using Agilent's ChemStation software. The Microsoft Excel software was used for statistical processing [14].…”

Section: Apparatusmentioning

confidence: 99%

Section: Human Serum Samplesmentioning

confidence: 99%

Section: Human Serum Samplesmentioning

confidence: 99%

See 3 more Smart Citations

A reliable chromatographic method for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum

Džodić¹,

Veličković‐Radovanović²,

Koraćević³

et al. 2020

Trop. J. Pharm Res

Self Cite

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Utility of salivary mycophenolic acid concentration monitoring: Modeling and Monte Carlo validation approach

Catić‐Đorđević

Stefanović

Pavlović

et al. 2022

Pharmacology Res & Perspec

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The results of the previous studies demonstrated an association between mycophenolic acid (MPA) exposure, serum albumin level (ALB), and adverse effects in kidney transplant patients. The aim was the identification of mathematical correlation and association between both, total and unbound MPA concentration in relation to ALB, body mass (BM), age and estimated glomerular filtration rate (eGFR) in stable kidney transplant recipients. Furthermore, investigation was conducted with the aim to clarify the role of salivary concentration (C SAL ) of MPA in adverse effect profile. In order to analyze the association between total and salivary concentration of MPA in relation to ALB, BM, age and eGFR, a least squares method for determining the correlation between these parameters was performed. In addition, derived mathematical model based on experimental data can also be performed and simulated through the Monte Carlo (MC) approach. Adverse effects were grouped according to the nature of symptoms and scored by a previously published validated system. Numerically calculated values of C SAL from the models [C SAL = f (ALB, BM, age, eGFR, C P ) = a 00 + a 10 *(ALB, BM, age, eGFR) + a 01 *C P ] were then compared with those from validation set of patients, where the best fitting model was for ALB [C SAL = 54.96–1.64*ALB +13.4*C P ]. Adverse effects estimation showed the difference in esthetic score, positively correlated with C SAL in the lower ALB group (145.41 ± 219.02 vs. 354.08 ± 262.19; with statistical significance p = .014) and almost significant for gastrointestinal score (167.69 ± 174.79 vs. 347.55 ± 320.95; p = .247). The study showed that C SAL MPA may contribute to management of adverse effects, but these findings require confirmation of clinical utility.

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Adverse effects of mycophenolic acid in renal transplant recipients: gender differences

Spasić

Catić‐Đorđević

Veličković‐Radovanović

et al. 2019

Int J Clin Pharm

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Validation of HPLC Method for the Determination of Mycophenolic Acid in Human Plasma Obtained From Renal Transplant Recipients

Cited by 4 publications

References 15 publications

A reliable chromatographic method for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum

A reliable chromatographic method for the simultaneous determination of ciprofloxacin and moxifloxacin in human serum

Utility of salivary mycophenolic acid concentration monitoring: Modeling and Monte Carlo validation approach

Adverse effects of mycophenolic acid in renal transplant recipients: gender differences

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