Setting system suitability criteria for detectability in high-performance liquid chromatography methods using signal-to-noise ratio statistical tolerance intervals

Coleman, J. E.; Wrzosek, Thomas J.; Roman, R.; Peterson, John J.; McAllister, Paul R.

doi:10.1016/s0021-9673(01)00669-0

Cited by 18 publications

(11 citation statements)

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“…Polyphenols were quantitated by means of calibration curves (peak area divided by IS area vs. quotient of polyphenol and the IS concentration). Linearity was shown for 0.4-600 mg/L; LOQs ranged from 0.4 to 0.9 mg/L, LODs from 0.2 to 0.4 mg/L with an S/N of 3:1 [17], respectively. All experiments were performed in triplicate.…”

Section: Quantitation Of Apple Juice and Ileostomy Fluidsmentioning

confidence: 92%

Colonic availability of apple polyphenols - A study in ileostomy subjects

Kahle

Kraus

Scheppach

et al. 2005

Mol. Nutr. Food Res.

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Nutrition is thought to play an essential role in the pathogenesis of inflammatory and malignant gastrointestinal diseases. It is well known that plant ingredients such as polyphenols and flavonoids show anticarcinogenic effects both in vitro and in animal experiments, and may thus reduce the risk of colorectal cancer in man. The aim of the study was to determine the amount of polyphenols reaching the colon after oral intake of apple juice. After consumption of a polyphenol-free diet 11 healthy ileostomy volunteers drank 1 L of a polyphenol-rich cloudy apple juice. Ileostomy effluent was collected immediately before and 1, 2, 4, 6, and 8 h after consumption of apple juice. A broad spectrum of polyphenols was identified using HPLC-diode array detection (HPLC-DAD) as well as HPLC-ESI-MS/MS; quantitation was performed with HPLC-DAD. Most of the orally administered apple polyphenols were absorbed from or metabolized in the small intestine. Between 0 and 33% of the oral dose was recovered in the ileostomy bags with a maximum of excretion after 2 h. Phloretin glucuronide as product of polyphenol metabolism was detected in the ileostomy effluent. The present results show that most of the apple juice polyphenols are absorbed in the small intestine. Minor amounts of unmetabolized polyphenols are recovered in the ileostomy effluent, which would reach the colon under physiologic circumstances. These data have to be considered when polyphenols are used in model systems to show preventive effects in colorectal carcinogenesis.

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Section: Quantitation Of Apple Juice and Ileostomy Fluidsmentioning

confidence: 92%

Colonic availability of apple polyphenols - A study in ileostomy subjects

Kahle

Kraus

Scheppach

et al. 2005

Mol. Nutr. Food Res.

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“…A system suitability test was performed on the HPLC system by injecting six injections of a solution containing test concentration of SFN at 20 μg mL −1 . The parameters, such as percentage recovery, RSD and SEM, were estimated (Coleman, Wrzosek, Roman, Peterson, & McAllister, ).…”

Section: Methodsmentioning

confidence: 99%

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Sharma

Khurana

Jain

et al. 2018

Biomedical Chromatography

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The current research work envisages an analytical quality by design-enabled development of a simple, rapid, sensitive, specific, robust and cost-effective stability-indicating reversed-phase high-performance liquid chromatographic method for determining stress-induced forced-degradation products of sorafenib tosylate (SFN). An Ishikawa fishbone diagram was constructed to embark upon analytical target profile and critical analytical attributes, i.e. peak area, theoretical plates, retention time and peak tailing. Factor screening using Taguchi orthogonal arrays and quality risk assessment studies carried out using failure mode effect analysis aided the selection of critical method parameters, i.e. mobile phase ratio and flow rate potentially affecting the chosen critical analytical attributes. Systematic optimization using response surface methodology of the chosen critical method parameters was carried out employing a two-factor-three-level-13-run, face-centered cubic design. A method operable design region was earmarked providing optimum method performance using numerical and graphical optimization. The optimum method employed a mobile phase composition consisting of acetonitrile and water (containing orthophosphoric acid, pH 4.1) at 65:35 v/v at a flow rate of 0.8 mL/min with UV detection at 265 nm using a C column. Response surface methodology validation studies confirmed good efficiency and sensitivity of the developed method for analysis of SFN in mobile phase as well as in human plasma matrix. The forced degradation studies were conducted under different recommended stress conditions as per ICH Q1A (R2). Mass spectroscopy studies showed that SFN degrades in strongly acidic, alkaline and oxidative hydrolytic conditions at elevated temperature, while the drug was per se found to be photostable. Oxidative hydrolysis using 30% H O showed maximum degradation with products at retention times of 3.35, 3.65, 4.20 and 5.67 min. The absence of any significant change in the retention time of SFN and degradation products, formed under different stress conditions, ratified selectivity and specificity of the systematically developed method.

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“…This optimization methodology includes the following four steps: Table 3. To evaluate the outcome of the calibration design experiments, the signal to noise ratio and peak area of a certain peak were used as a response value (R) [28].…”

Section: Optimization Of Elsd Settings and Experimental Parameters Bymentioning

confidence: 99%

Fully Automated Three‐Dimensional Column‐Switching SPE–FIA–HPLC System for the Characterization of Lipids by a Single Injection: Part I. Instrumental Design and Chemometric Approach to Assess the Effect of Experimental Settings on the Response of ELSD

Arslan

Kara

2015

J Americ Oil Chem Soc

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Setting system suitability criteria for detectability in high-performance liquid chromatography methods using signal-to-noise ratio statistical tolerance intervals

Cited by 18 publications

References 1 publication

Colonic availability of apple polyphenols - A study in ileostomy subjects

Colonic availability of apple polyphenols - A study in ileostomy subjects

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Fully Automated Three‐Dimensional Column‐Switching SPE–FIA–HPLC System for the Characterization of Lipids by a Single Injection: Part I. Instrumental Design and Chemometric Approach to Assess the Effect of Experimental Settings on the Response of ELSD

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