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Development and val...
Development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry method for the quantification of the antimalarial drug pyronaridine in human whole blood
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- Schouten, Wietse M. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.
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- Roseboom, Ignace C. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.
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- Lucas, Luc (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.
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- Tshiongo, Japhet Kabalu (author)
- Univ Kinshasa UNIKIN, Dept Trop Med, Kinshasa, DEM REP CONGO.;Univ Amsterdam, Acad Med Ctr, Dept Med Microbiol & Infect Prevent, Lab Expt Parasitol,Med Ctr, Amsterdam, Netherlands.;Amsterdam Inst Infect & Immun, Infect Dis Programme, Amsterdam, Netherlands.
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- Mavoko, Hypolite Muhindo (author)
- Univ Kinshasa UNIKIN, Dept Trop Med, Kinshasa, DEM REP CONGO.
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- Kayentao, Kassoum (author)
- Univ Sci Tech & Technol Bamako USTTB, Malaria Res & Training Ctr MRTC, Bamako, Mali.
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- Rosing, Hilde (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.
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- Huitema, Alwin D. R. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Princess Maxima Ctr, Dept Pharmacol, Utrecht, Netherlands.;Univ Utrecht, Univ Med Ctr Utrecht, Dept Clin Pharm, Utrecht, Netherlands.
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- Beijnen, Jos H. (author)
- Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Univ Utrecht, Utrecht Inst Pharmaceut Sci, Utrecht, Netherlands.
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- Dorlo, Thomas, PhD, 1983- (author)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap,Institutionen för farmaci,Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.
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Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands Univ Kinshasa UNIKIN, Dept Trop Med, Kinshasa, DEM REP CONGO.;Univ Amsterdam, Acad Med Ctr, Dept Med Microbiol & Infect Prevent, Lab Expt Parasitol,Med Ctr, Amsterdam, Netherlands.;Amsterdam Inst Infect & Immun, Infect Dis Programme, Amsterdam, Netherlands. (creator_code:org_t)
- Elsevier, 2024
- 2024
- English.
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In: Journal of Pharmaceutical and Biomedical Analysis. - : Elsevier. - 0731-7085 .- 1873-264X. ; 245
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Abstract
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- Malaria remains a major health concern, aggravated by emerging resistance of the parasite to existing treatments. The World Health Organization recently endorsed the use of artesunate-pyronaridine to treat uncomplicated malaria. However, there is a lack of clinical pharmacokinetic (PK) data of pyronaridine, particularly in special populations such as children and pregnant women. Existing methods for the quantification of pyronaridine in biological matrices to support PK studies exhibit several drawbacks. These include limited sensitivity, a large sample volume required, and extensive analysis time. To overcome these limitations, an ultra-performance reversed-phase liquid chromatography tandem-mass spectrometry method to determine pyronaridine was developed and validated according to international guidelines. The method enabled fast and accurate quantification of pyronaridine in whole blood across a clinically relevant concentration range of 0.500-500 ng/mL (r2 >= 0.9963), with a required sample volume of 50 mu L. Pyronaridine was extracted from whole blood using liquidliquid extraction, effectively eliminating the matrix effect and preventing ion enhancement or suppression. The method achieved a satisfactory reproducible sample preparation recovery of 77%, accuracy (as bias) and precision were within +/- 8.2% and <= 5.3%, respectively. Stability experiments demonstrated that pyronaridine was stable for up to 315 days when stored at - 70 degrees C. Adjustments to the chromatographic system substantially reduced carry-over and improved sensitivity compared to prior methods. The method was successfully applied to quantify pyronaridine in whole blood samples from a selection of pregnant malaria patients participating in the PYRAPREG clinical trial (PACTR202011812241529) in the Democratic Republic of the Congo, demonstrating its suitability to support future PK studies. Furthermore, the enhanced sensitivity allows for the determination of pyronaridine up to 42 days post-treatment initiation, enabling assessment of the terminal elimination half-life.
Subject headings
- NATURVETENSKAP -- Kemi -- Analytisk kemi (hsv//swe)
- NATURAL SCIENCES -- Chemical Sciences -- Analytical Chemistry (hsv//eng)
Keyword
- Pyronaridine
- UPLC-MS/MS
- Whole blood
- Pharmacokinetics
- Liquid-liquid extraction
Publication and Content Type
- ref (subject category)
- art (subject category)
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Schouten, Wietse ...
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Roseboom, Ignace ...
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Lucas, Luc
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Tshiongo, Japhet ...
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Mavoko, Hypolite ...
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Kayentao, Kassou ...
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Rosing, Hilde
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Huitema, Alwin D ...
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Beijnen, Jos H.
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Dorlo, Thomas, P ...
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- NATURAL SCIENCES
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NATURAL SCIENCES
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and Chemical Science ...
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Uppsala University