Ion mobility spectrometry for the simultaneous determination of diacetyl midecamycin and detergents in cleaning validation

Armenta, Sergio; Alcalà, Manel; Blanco, M.; González, Josep M.

doi:10.1016/j.jpba.2013.05.016

Cited by 3 publications

(2 citation statements)

References 18 publications

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“…In recent years, the use of IMS has increased significantly to enhance LC‐MS‐ and GC‐MS‐based processes to provide an alternative to established method validation approaches 39,45,46 . The developed method for identifying eight alkaloids was also confirmed using IMS.…”

Section: Resultsmentioning

confidence: 96%

Identification and quantification of eight alkaloids in Aconitum heterophyllum using UHPLC‐DAD‐QTOF‐IMS: A valuable tool for quality control

Punia

Joshi

Kumar

2022

Phytochemical Analysis

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Introduction: Aconitum spp. are prime medicinal plants rich in alkaloids and have been used as the main constituents of traditional medicine in India and China. The whole plant can be toxic and creates pathophysiological conditions inside the human body. Therefore, simultaneous quantification of alkaloids within plant parts and herbal medicines associated with this genus is essential for quality control.Objective: We aimed to develop and validate methods using ultra-high-performance liquid chromatography-diode array detector-quadrupole time-of-flight ion mobility mass spectrometry (UHPLC-DAD-QTOF-IMS) and to develop an analytical strategy for the identification and quantification of alkaloid compounds (aconitine, hypaconitine, mesaconitine, aconine, benzoylmesaconitine, benzoylaconine, bulleyaconitine A, and deoxyaconitine) from Aconitum heterophyllum. Methodology:We developed a simultaneous identification and quantification method for eight alkaloids using UHPLC-DAD-QTOF-IMS. The method was validated as per International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and also in IMS mode. Results:The developed method has good linearity (r 2 = 0.997-0.999), LOD (0.63-8.31 μg/mL), LOQ (0.63-2.80 μg/mL), recovery (86.01-104.33%), reproducibility, intra-and inter-day variability (<3.25%), and stability. Significant qualitative and quantitative variations were found among different plant parts (flower, leaf, stem, root, and tuber) and five market products of A. heterophyllum. Furthermore, a total of 21 metabolites were also profiled based on the fragmentation pattern of MS 2 using the validated method.Conclusion: An appropriate mobile phase using acetonitrile and water in a gradient elution gave a satisfactory chromatographic separation of eight Aconitum alkaloids with their adjacent peaks. Therefore, this method could provide a scientific and technical platform for quality control assurance.

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Section: Resultsmentioning

confidence: 96%

Identification and quantification of eight alkaloids in Aconitum heterophyllum using UHPLC‐DAD‐QTOF‐IMS: A valuable tool for quality control

Punia

Joshi

Kumar

2022

Phytochemical Analysis

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show abstract

“…The first application is cleaning validation, and a number of groups have published work where IMS has been used to check the surfaces of process equipment to ensure that contaminants from previous syntheses and cleaning products are not present before starting a new reaction. [20] IMS is particularly attractive here since swabs can be taken from the surface and then thermally desorbed enabling rapid analysis and potential identification of contaminants by their drift time. [21] The second application is the detection of active pharmaceutical ingredients and a number of drug substances both pharmaceutical and illicit, have been characterized by IMS.…”

Section: Introductionmentioning

confidence: 99%