Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

Karthikeyan, Kaliaperumal

doi:10.3797/scipharm.1007-20

Cited by 9 publications

(2 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The specificity of the method was confirmed by the well-resolved peaks of all four genotoxic impurities, indicating its ability to accurately separate and quantify specific compounds in the presence of other matrix components. This finding aligns with previous studies 25,26 where successful determination of specific impurities has been reported using headspace gas chromatography.…”

Section: Discussionsupporting

confidence: 92%

Development and Validation of Headspace-Gas Chromatography (HS-GC) Method for the Determination of Potential Genotoxic Impurities in Meloxicam

Amit B Bhosale , Ravi Yadev, Seema Kothari

2023

tjjpt

View full text Add to dashboard Cite

The development and validation of a specific Headspace-Gas Chromatography (HS-GC) method for the determination of genotoxic impurities (isopropyl chloride, propionaldehyde, 2-chloropropanol, and chloromethane) in Meloxicam. The chromatographic separation of these impurities was accomplished using a nitrogen carrier gas on a DB-624 (6% cyanopropyl phenyl + 94% dimethyl polysiloxane fused silica) (75 m x 0.53 mm, 3.0 µ) GC analytical column. The Flame Ionization Detector (FID) served as the detector with optimized temperatures set at 260°C for the detector and 240°C for the injector port. Additionally, an injection volume of 1.0 mL with a split ratio mode was employed. The performance of this method was assessed through parameters, including system suitability, specificity, linearity, range, accuracy, limit of detection (LOD), limit of quantification (LOQ) and precision. The limit of detection and limit of quantification for isopropyl chloride, propionaldehyde, 2-chloropropanol, and chloromethane were determined to be 2 and 4 ppm, respectively, and for chloromethane 0.8 and 1.6 respectively. The correlation coefficient of the linearity experiment was 0.999 for propionaldehyde, 2-chloropropanol, chloromethane and 1 for isopropyl chloride compounds. Furthermore, the accuracy assessment involved spiking the genotoxic impurities at various levels, demonstrating favourable recovery percentages well within the acceptable range of 80–120% of the limit level. These compelling results substantiate the suitability of the proposed HS-GC method for the accurate determination of isopropyl chloride, propionaldehyde, 2-chloropropanol, and chloromethane in Meloxicam.

show abstract

Section: Discussionsupporting

confidence: 92%

Development and Validation of Headspace-Gas Chromatography (HS-GC) Method for the Determination of Potential Genotoxic Impurities in Meloxicam

Amit B Bhosale , Ravi Yadev, Seema Kothari

2023

tjjpt

View full text Add to dashboard Cite

show abstract

“…In SHS, the samples are enclosed in a gas tight sealed vial and are heated at a defined temperature. [ 16 ] The developed method has been demonstrated to be a powerful tool to study the principal volatile compounds in crude and processed A. macrocephala .…”

Section: Introductionmentioning

confidence: 99%

Fast analysis of principal volatile compounds in crude and processed Atractylodes macrocephala by an automated static headspace gas chromatography-mass spectrometry

et al. 2014

View full text Add to dashboard Cite

Objective:Atractylodes macrocephala, a famous herbal medicine, is used extensively in the practice of Traditional Chinese Medicine (TCM). Processing procedure is a common approach that usually occurs before A. macrocephala is prescribed. This paper describes a sensitive and specific assay for the determination of principal volatile compounds in crude and processed A. macrocephala.Materials and Methods:The present study concentrated on the development of a static headspace gas chromatography-mass spectrometry (SHS-GC/MS) for separating and identifying of volatile compounds from crude and processed A. macrocephala samples.Results:The results showed that the volatile oil in crude and processed A. macrocephala was markedly quantitatively and qualitatively different. Processing resulted in the reduction of volatile oil contents and variation of chemical compositions in A. macrocephala.Conclusion:The proposed method proved that SHS-GC/MS is rapid and specific, and should also be useful for evaluating the quality of crude and processed medicinal herbs.

show abstract

Enzyme‐based detection of epoxides using colorimetric assay integrated with smartphone imaging

Gul

Bogale

Deng

et al. 2020

Biotech and App Biochem

View full text Add to dashboard Cite

Epoxides are widely used chemicals, the determination of which is of paramount importance. Herein, we present an enzyme‐based approach for noninstrumental detection of epoxides in standard solution and environmental samples. Halohydrin dehalogenase (HheC) as a biological recognition element and epichlorohydrin as a model analyte were evaluated for sensing. The detection is based on the color change of the pH indicator dye bromothymol blue caused by the HheC‐catalyzed ring‐opening of the epoxide substrate. The color change is then exploited for the determination of epoxide using a smartphone as an image acquisition and data processing device, eliminating the need for computer‐based image analysis software. The color parameters were systematically evaluated to determine the optimum quantitative analytical parameter. Under optimal conditions, the proposed enzyme‐based detection system showed a linear range of 0.13–2 mM with a detection limit of 0.07 mM and an assay time of 8 Min. In addition, the repeatability expressed as relative standard deviation was found to be below 5% (n = 6). Validation with gas chromatographic analyses showed that the proposed enzyme‐based epoxide detection could be an alternative way in the quantitative determination of epoxides, and particularly useful in resource‐limited settings.

show abstract

Determination of Residual Epichlorohydrin in Sevelamer Hydrochloride by Static Headspace Gas Chromatography with Flame Ionization Detection

Cited by 9 publications

References 12 publications

Development and Validation of Headspace-Gas Chromatography (HS-GC) Method for the Determination of Potential Genotoxic Impurities in Meloxicam

Development and Validation of Headspace-Gas Chromatography (HS-GC) Method for the Determination of Potential Genotoxic Impurities in Meloxicam

Fast analysis of principal volatile compounds in crude and processed Atractylodes macrocephala by an automated static headspace gas chromatography-mass spectrometry

Enzyme‐based detection of epoxides using colorimetric assay integrated with smartphone imaging

Contact Info

Product

Resources

About