Design and evaluation of a multi-detection system composed of ultraviolet, evaporative light scattering and inductively coupled plasma mass spectrometry detection for the analysis of pharmaceuticals by liquid chromatography

Pereira, Alberto dos Santos; Schelfaut, Marc; Lynen, Frédéric; Sandra, Patrick

doi:10.1016/j.chroma.2008.01.030

Cited by 19 publications

(16 citation statements)

References 32 publications

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“…Nebulization spray chambers are commonly used in ICP-MS for direct introduction of water samples [18] and are applied more recently as interface for coupling LC to ICP-MS [8,9]. An aerosol is generated through the interaction of a high speed gas (with flow rates between 0. min) and the liquid phase eluting at the exit of the nebulizer.…”

Section: Optimization Of the Electron Capture Detection Responsementioning

confidence: 99%

“…More recently, inductively coupled plasma-MS (ICP-MS) has been coupled to RP-LC for sensitive element specific detection [8,9]. For RP-LC/ICP-MS we used a Scotttype spray chamber and a concentric nebulizer [8]. Out of curiosity, the same interface was evaluated for the hyphenation of RP-LC to electron capture detection (ECDNi 63 ) and the results are reported in this contribution.…”

Section: Introductionmentioning

confidence: 99%

“…Detectors commonly applied include UV/DAD detection, mass spectrometric detection (MS and MS/MS) [1], evaporative light scattering detection (ELSD) [2,3], charged aerosol detection (CAD) [4,5], and chemiluminescent nitrogen detection (CLND) [6,7]. More recently, inductively coupled plasma-MS (ICP-MS) has been coupled to RP-LC for sensitive element specific detection [8,9]. For RP-LC/ICP-MS we used a Scotttype spray chamber and a concentric nebulizer [8].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of electron capture detection in reversed‐phase HPLC for pharmaceutical analysis

Pereira

Szücs

Sandra³

2008

J of Separation Science

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The coupling of RP-LC to electron capture detection (ECDNi(63)) is described. To reduce the amount of mobile phase entering into the detector, interfacing was performed via a Scott-type spray chamber. The performance of RP-LC/ECDNi(63) was evaluated for pharmaceutical analysis and the results show that the system is able to work in a routine environment using columns with 2 mm id and common amounts of the organic modifiers methanol or ACN in the mobile phase. Because of the high sensitivity and selectivity toward electrophilic compounds, the use of this detector opens possibilities for the analysis of impurities down to the 0.05% level of active pharmaceutical ingredients (API).

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Section: Optimization Of the Electron Capture Detection Responsementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of electron capture detection in reversed‐phase HPLC for pharmaceutical analysis

Pereira

Szücs

Sandra³

2008

J of Separation Science

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“…[21][22][23] Applications of ICP-MS to the control of residual metals and speciation studies concerning several metals in APIs have been successfully performed. 24,25 Moreover, ICP-MS has been used for organic analyses because of its highly efficient ICP ionization and selective, sensitive MS detection.…”

Section: Introductionmentioning

confidence: 99%

Sensitive Quantitation of Residual Phenylhydrazine in Antipyrine by LC-ICP-MS with Iodo Derivatization

Harigaya¹,

Horimoto²,

Nishi

et al. 2014

ANAL. SCI.

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Phenylhydrazine is a genotoxic impurity commonly used as a raw material in active pharmaceutical ingredients. In this study, a novel method, using inductively coupled plasma-mass spectrometry combined with two-dimensional liquid chromatography (LC-ICP-MS), was employed for the quantitation of residual phenylhydrazine in antipyrine. The compound 2,3,5-triiodobenzoyl chloride, which contains three iodine atoms, was investigated as a derivatization reagent. The DL 0.06 ppm was obtained, and the method was applied to the quantitation of residual phenylhydrazine in antipyrine. No residual phenylhydrazine was detected in five lots of antipyrine obtained from the commercial source.

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“…[20][21][22][23] In addition, the trace-level determination of aluminum in large volume parenteral drug products was successful. 24,25 A method for determining GTIs using ICP-MS has been investigated with a focus on the high-efficiency ionization source of ICP for MS detection.…”

Section: Introductionmentioning

confidence: 99%

Novel Sensitive Determination Method for a Genotoxic Alkylating Agent, 4-Chloro-1-butanol, in Active Pharmaceutical Ingredients by LC-ICP-MS Employing Iodo Derivatization

Harigaya¹,

Yaku²,

Nishi

et al. 2014

ANAL. SCI.

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An alkylating agent, 4-chloro-1-butanol, is a genotoxic impurity (GTI); it may be generated during the synthesis of active pharmaceutical ingredients (APIs). For the trace-level detection of GTIs in APIs, usually, gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) is employed. In this study, a novel LC-inductively coupled plasma (ICP)-MS method was developed and validated. Linearity was observed over the 0.5 -50 ppm (μg/g API) range, with an R 2 value of 0.9994. The detection limit (DL) and quantitation limit (QL) were 0.2 and 0.5 ppm, respectively. The DL and QL values are well over the thresholds specified in the guidelines. The accuracy was 95.1 -114.7% for concentrations of 1 -50 ppm, and the relative standard deviation of the spiked recovery test's repeatability was 6.2%. In addition, six lots of an API were analyzed, and all results were lower than the reported threshold (1 ppm).

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Design and evaluation of a multi-detection system composed of ultraviolet, evaporative light scattering and inductively coupled plasma mass spectrometry detection for the analysis of pharmaceuticals by liquid chromatography

Cited by 19 publications

References 32 publications

Evaluation of electron capture detection in reversed‐phase HPLC for pharmaceutical analysis

Evaluation of electron capture detection in reversed‐phase HPLC for pharmaceutical analysis

Sensitive Quantitation of Residual Phenylhydrazine in Antipyrine by LC-ICP-MS with Iodo Derivatization

Novel Sensitive Determination Method for a Genotoxic Alkylating Agent, 4-Chloro-1-butanol, in Active Pharmaceutical Ingredients by LC-ICP-MS Employing Iodo Derivatization

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