A solvent-free headspace GC/MS method for sensitive screening of <i>N</i>-nitrosodimethylamine in drug products

Lee, Do Hee; Hwang, Su Hyeon; Park, Seoungchul; Lee, Jeongmi; Oh, Han Bin; Han, Sang Beom; Liu, Kwang Hyun; Lee, Yong Moon; Pyo, Hee Soo; Hong, Jongki

doi:10.1039/d1ay01036k

Cited by 9 publications

(7 citation statements)

References 10 publications

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“…A headspace GC‐MS is an alternative approach to this relatively time‐consuming sample preparation. A solvent‐free headspace GC‐MS method for the determination of NDMA in several APIs and drug products, including ranitidine, nizatidine, metformin, acetaminophen, chlorpheniramine, diphenhydramine, and clonixin, was developed (Lee et al, 2021). The LOQ of the method was 5 μg/kg.…”

Section: Ms‐based Methods In the Analysis Of Small‐molecule Chemical ...mentioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

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The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small‐molecule chemical drugs and biopharmaceuticals. Important features of MS‐based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

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Section: Ms‐based Methods In the Analysis Of Small‐molecule Chemical ...mentioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

View full text Add to dashboard Cite

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“…Enzyme-linked immunosorbent assays have also been used for opioid detection [47,48]. Liquid chromatography-mass spectrometry [49][50][51][52][53][54] and gas chromatography-mass spectrometry [55][56][57][58][59][60][61][62] are the most widely used methods for nitrosamine analysis. However, while these methods are commonly used for identifying illicit drugs, they tend to be both expensive and time-consuming.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Sensors, Biosensors, and Optical Sensors for the Detection of Opioids and Their Analogs: Pharmaceutical, Clinical, and Forensic Applications

Fakayode,

Brady,

Grant

et al. 2024

Chemosensors

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Pharmaceutical opioids are intravenously or orally administered analgesics. While they are effective in relieving chronic and acute pain, their narrow window of therapeutic use contributes to the high occurrence of abuse. The associated abuse of this family of drugs can be correlated to the increase in dependency, overdose, and death of users. The negative effects of opioids extend beyond the physical and psychological effects experienced by the user to their unregulated synthesis and sale, which contribute to socioeconomic challenges and are a biproduct of this global public health epidemic. From clinical to point-of-care applications, the detection and real-time monitoring of this family of drug is critical in the fight to decrease abuse and improve use in clinical settings. Chromatographic separations and chromatography–mass spectrometry are traditional methods of opioid analyses, but the high cost, long analysis time, and absence of portability highlight the need for the development of fast, in situ, point-of-care analysis, or of community drug monitoring services. This review highlights recent electrochemical and optical (FTIR, Raman, colorimetric, and fluorescent) advances and biosensors for pharmaceutical and illicit opioid analysis. Specifically, an emphasis is placed on the detection of opioids and their metabolites in biological samples and in vitro cellular assays for clinical diagnosis and forensic applications. The challenges and prospects of the role of electrochemical sensors, biosensors, and optical sensors for opioid analysis in promoting clinical diagnosis, forensic study, point-of-care, and community drug monitoring services to reduce harm are also provided.

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“…The traditional detection methods include liquid chromatography-mass spectrometry (LC-MS), high-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS). [11][12][13] Despite proving to be powerful and effective tools for detecting trace amounts of hazardous substances, 14,15 these methods still have inherent limitations such as complex sample pretreatment, extended detection time, elevated detection cost, and the necessity for skilled professionals. 16 Therefore, achieving fast, simple and accurate detection using a small amount of sample is the main focus for researchers.…”

Section: Introductionmentioning

confidence: 99%

Ag-coated tetrapod gold nanostars (Au@AgNSs) for acetamiprid determination in tea using SERS combined with microfluidics

Ke,

Yin,

Jayan

et al. 2024

Anal. Methods

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A solvent-free headspace GC/MS method for sensitive screening of N-nitrosodimethylamine in drug products

Abstract: A solvent-free headspace gas chromatography – mass spectrometry (SF-HS-GC/MS) method was developed and validated for screening of N-nitrosodimethylamine (NDMA) in various active pharmaceutical ingredients (APIs) and drug products. Experimental parameters...

Cited by 9 publications

References 10 publications

What is the role of current mass spectrometry in pharmaceutical analysis?

What is the role of current mass spectrometry in pharmaceutical analysis?

Electrochemical Sensors, Biosensors, and Optical Sensors for the Detection of Opioids and Their Analogs: Pharmaceutical, Clinical, and Forensic Applications

Ag-coated tetrapod gold nanostars (Au@AgNSs) for acetamiprid determination in tea using SERS combined with microfluidics

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