Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography

Chung, Hyo Helen; Zhou, Chengfeng; Khor, Hui Koon; Qiu, Jinshu

doi:10.1016/j.chroma.2010.12.073

Cited by 16 publications

(7 citation statements)

References 18 publications

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“…Sample preparation to remove the proteins are necessary to avoid column fouling. HPLC-RAM-ELSD method can be used for protein containing solutions, but the approach was only handled with low protein concentrations [447].…”

Section: Photo-oxidation Of Excipientsmentioning

confidence: 99%

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

et al. 2021

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UV and ambient light-induced modifications and related degradation of therapeutic proteins are observed during manufacturing and storage. Therefore, to ensure product quality, protein formulations need to be analyzed with respect to photo-degradation processes and eventually protected from light exposure. This task usually demands the application and combination of various analytical methods. This review addresses analytical aspects of investigating photo-oxidation products and related mediators such as reactive oxygen species generated via UV and ambient light with well-established and novel techniques.

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Section: Photo-oxidation Of Excipientsmentioning

confidence: 99%

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

et al. 2021

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“…Currently, a number of analytical techniques have been applied to the determination of Poloxamers including colorimetric methods [ 13 ], various chromatographic techniques [ 14 , 15 ], etc. However, many of them suffer from disadvantages such as poor selectivity and reproducibility, low sensitivity, long analytical run time, requirement of a large sample volume, and complex sample preparation.…”

Section: Introductionmentioning

confidence: 99%

Tissue Distribution Study of Poloxamer188 in Rats by Ultra-High-Performance Liquid Chromatography Quadrupole Time of Flight/Mass Spectrometry with MSALL-Based Approach

Feng

et al. 2021

Molecules

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Poloxamer188 (PL188), as one of the most commonly used pharmaceutical excipients, has unique physicochemical properties and good biocompatibility, and so is playing an increasingly extensive role in the field of medicine. Currently, there are few studies on the tissue distribution of PL188 in vivo. In this study, the LC-MS method based on MSALL technique of quadrupole time of flight mass spectrometry for absolute quantitative analysis of poloxamer 188 in biological substrates was established for the first time. The tissue distribution of poloxamer188 in SD rats were studied using the established quantitative analysis method. To explore the distribution of PL188 in organs and tissues, PL188 was administered via rat tail vein at a dose of 5 mg/kg. Eight kinds of tissues including heart, liver, spleen, lung, kidney, stomach, muscle and brain of rats were collected at 0.25 h, 1 h and 4 h after administration. Tissue distributions showed the highest level was observed in kidney, then in stomach, which indicated PL188 mainly bioaccumulated in the kidney. This study can provide references for the further study of PL188.

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“…The x ‐ and y ‐values of PL188 are ~80 and 27, respectively. PL188 is approved as a food additive, drug excipient and drug delivery vehicle by the US Food and Drug Administration, US Pharmacopeia, European Pharmacopoeia and Chinese Pharmacopoeia for its unique physicochemical properties and biocompatibilities (Chime et al, 2020; Chung et al, 2011; Chunhachaichana et al, 2019; Grapentinab et al, 2020; Moloughney & Weisleder, 2012). The chemical structure of PL188 is shown in Figure 1.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, PL188 can be used as local drug delivery of in situ gels. Applications (such as emulgator, stabilizer, solubilizer and sorbefacien) of PL188 in pharmaceutics and biomedical fields are increasing (Chung et al, 2011) and it is necessary to perform in‐depth research on it.…”

Section: Introductionmentioning

confidence: 99%

A MS^ALL quantitative method for the determination of Poloxamer 188 in rat plasma by UHPLC–Q‐TOF/MS and its application to pharmacokinetic study

Feng

et al. 2021

Biomedical Chromatography

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Poloxamer (PL)188 is a commonly used pharmaceutical excipient with unique physicochemical properties. In this study, an MSALL quantitative method for the determination of PL188 in rat plasma by UHPLC–Q‐TOF/MS was developed and validated. PL188 was analyzed on PLRP‐S reversed‐phase column (50 × 4.6 mm, 8 μm, 1,000 Å) with mobile phase 0.1% formic acid–water and 0.1% formic acid in acetonitrile–isopropanol (2:3, v/v). The liner range was 0.1–10.0 μg/ml. A pharmacokinetic study was performed on rats at a dose of 5 mg/kg by intravenous injection. The pharmacokinetic parameters of intravenous injection were as follows: half‐life was 2.0 ± 1.1 h, volume of distribution was 5.1 ± 3.2 L/kg, area under the concentration–time curve was 3.0 ± 0.6 μg/L h and clearance was 1.7 ± 0.3 L/h/kg. The results indicated that PL188 could be rapidly distributed to tissues with a high clearance rate. This study can provide a good reference for the further study of PL188.

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Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography

Cited by 16 publications

References 18 publications

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

Tissue Distribution Study of Poloxamer188 in Rats by Ultra-High-Performance Liquid Chromatography Quadrupole Time of Flight/Mass Spectrometry with MSALL-Based Approach

A MS^ALL quantitative method for the determination of Poloxamer 188 in rat plasma by UHPLC–Q‐TOF/MS and its application to pharmacokinetic study

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Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography

Cited by 16 publications

References 18 publications

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques

Tissue Distribution Study of Poloxamer188 in Rats by Ultra-High-Performance Liquid Chromatography Quadrupole Time of Flight/Mass Spectrometry with MSALL-Based Approach

A MSALL quantitative method for the determination of Poloxamer 188 in rat plasma by UHPLC–Q‐TOF/MS and its application to pharmacokinetic study

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A MS^ALL quantitative method for the determination of Poloxamer 188 in rat plasma by UHPLC–Q‐TOF/MS and its application to pharmacokinetic study