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Molecules
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Method Development and Validation in Food and Pharmaceutical Analysis IV
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Method Development and Validation in Food and Pharmaceutical Analysis IV

A special issue of Molecules (ISSN 1420-3049). This special issue belongs to the section "Analytical Chemistry".

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 4867

Special Issue Editors

Prof. Dr. In-Soo Yoon

E-Mail Website
Guest Editor
Department of Manufacturing Pharmacy, College of Pharmacy and Research Institute for Drug Development, Pusan National University, Geumjeong-gu, Busan 46241, Republic of Korea
Interests: bioanalysis; biopharmaceutics; DMPK; PBPK/PD modeling
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Hyun-Jong Cho

E-Mail Website
Guest Editor
College of Pharmacy, Kangwon National University, Chuncheon 24341, Republic of Korea
Interests: spectroscopy; imaging analysis; formulation; drug delivery system
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Analytical chemistry is the study of the separation, identification, and quantification of natural and artificial materials composed of one or more compounds or elements. The rapid growth of the food and pharmaceutical industries and the production of drugs and functional foods around the world have brought forward an inevitable rise in the demand to seek novel and systematic analytical techniques. As a consequence, analytical method development and validation have become a crucial prerequisite for achieving reliable analytical data required to support food and pharmaceutical development processes.

This Special Issue on “Method Development and Validation in Food and Pharmaceutical Analysis IV” will cover a wide range of topics including, but not limited to, new analytical and bioanalytical methods relevant to the separation, identification, and determination of substances in pharmaceutics, pharmacokinetics, nanobiotechnology, clinical chemistry, biomedical engineering, and related disciplines.

We warmly invite our colleagues to submit their original contributions to this Special Issue in order to provide recent updates regarding analytical methods for drugs, biologics, phytochemicals, and other organic/inorganic materials related to food and pharmaceutical sciences that are appealing to readers.  

Prof. Dr. In-Soo Yoon
Prof. Dr. Hyun-Jong Cho
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Molecules is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • HPLC
  • bioanalysis
  • phytochemicals
  • pharmacokinetics
  • mass spectrometry
  • functional food
  • biopharmaceutics
  • natural and synthetic polymers
  • inorganic materials
  • pharmaceutical formulations
  • imaging analysis
  • spectroscopy

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Published Papers (3 papers)

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Research

18 pages, 5384 KiB  
Article
Rat Pharmacokinetics and In Vitro Metabolite Identification of KM-819, a Parkinson’s Disease Candidate, Using LC-MS/MS and LC-HRMS
by Hae-In Choi, Taeheon Kim, Jin Woo Kim, Gi Ju Lee, Jinyoung Choi, Yoon-Jee Chae, Eunhee Kim and Tae-Sung Koo
Molecules 2024, 29(5), 1004; https://doi.org/10.3390/molecules29051004 - 25 Feb 2024
Cited by 1 | Viewed by 1769
Abstract
FAF1 (FAS-associated factor 1) is involved in the activation of Fas cell surface death receptors and plays a role in apoptosis and necrosis. In patients with Parkinson’s disease, FAF1 is overexpressed in dopaminergic neurons in the substantia nigra. KM-819, an FAF1 inhibitor, has [...] Read more.
FAF1 (FAS-associated factor 1) is involved in the activation of Fas cell surface death receptors and plays a role in apoptosis and necrosis. In patients with Parkinson’s disease, FAF1 is overexpressed in dopaminergic neurons in the substantia nigra. KM-819, an FAF1 inhibitor, has shown potential for preventing dopaminergic neuronal cell death, promoting the degradation of α-synuclein and preventing its accumulation. This study aimed to develop and validate a quantitative analytical method for determining KM-819 levels in rat plasma using liquid chromatography–tandem mass spectrometry. This method was then applied to pharmacokinetic (PK) studies in rats. The metabolic stability of KM-819 was assessed in rat, dog, and human hepatocytes. In vitro metabolite identification and metabolic pathways were investigated in rat, dog, and human hepatocytes. The structural analog of KM-819, namely N-[1-(4-bromobenzyl)-3,5-dimethyl-1H-pyrazol-4-yl]-2-(phenylsulfanyl) acetamide, served as the internal standard (IS). Proteins were precipitated from plasma samples using acetonitrile. Analysis was carried out using a reverse-phase C18 column with a mobile phase consisting of 0.1% formic acid in distilled water and 0.1% formic acid in acetonitrile. The analytical method developed for KM-819 exhibited linearity within the concentration range of 0.002–10 μg/mL in rat plasma. The precision and accuracy of the intra- and inter-day measurements were <15% for the lower limit of quantification (LLOQ) and all quality control samples. KM-819 demonstrated stability under various sample storage conditions (6 h at room temperature (25 °C), four weeks at −20 °C, three freeze-thaw cycles, and pretreated samples in the autosampler). The matrix effect and dilution integrity met the criteria set by the Food and Drug Administration and the European Medicines Agency. This sensitive, rapid, and reliable analytical method was successfully applied in pharmacokinetic studies in rats. Pharmacokinetic analysis revealed the dose-independent kinetics of KM-819 at 0.5–5 mg/kg, with a moderate oral bioavailability of ~20% in rats. The metabolic stability of KM-819 was also found to be moderate in rat, dog, and human hepatocytes. Metabolite identification in rat, dog, and human hepatocytes resulted in the discovery of six, six, and eight metabolites, respectively. Glucuronidation and mono-oxidation have been proposed as the major metabolic pathways. Overall, these findings contribute to a better understanding of the pharmacokinetic characteristics of KM-819, thereby aiding future clinical studies. Full article
(This article belongs to the Special Issue Method Development and Validation in Food and Pharmaceutical Analysis IV)
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18 pages, 1020 KiB  
Article
The Development, Validation, and Application of a UHPLC-HESI-MS Method for the Determination of 17 Cannabinoids in Cannabis sativa L. var. sativa Plant Material
by Joanna Kanabus, Marcin Bryła and Marek Roszko
Molecules 2023, 28(24), 8008; https://doi.org/10.3390/molecules28248008 - 8 Dec 2023
Cited by 1 | Viewed by 1317
Abstract
Cannabinoids are an important group of secondary metabolites found in the plant Cannabis sativa L. The growing interest in the use of hemp in food production (e.g., hemp teas, hemp cookies) makes it necessary to develop a method for determining these compounds in [...] Read more.
Cannabinoids are an important group of secondary metabolites found in the plant Cannabis sativa L. The growing interest in the use of hemp in food production (e.g., hemp teas, hemp cookies) makes it necessary to develop a method for determining these compounds in the plant, both fresh and dried. The selection of a suitable extraction liquid for the extraction of cannabinoids and the development of a method for the determination of 17 cannabinoids is a prelude to the development of an effective method for the extraction of these compounds. In the present study, a novel, simple, and efficient method was developed and validated for the determination of up to 17 cannabinoids in fresh plant parts (inflorescences and leaves) of Cannabis sativa L. and in dried material, including hemp teas. Analyses were performed using ultra-high-performance liquid chromatography-Q-Exactive Orbitrap mass spectrometry setup operating with a heated electrospray interface (UHPLC-HESI-MS). Based on the comparison, methanol was selected as the best for the extraction of cannabinoids from fresh and dried material. The efficiency and validity of the method were assessed using certified reference material (dried Cannabis) and confirmed by z-score from participation in an international proficiency test conducted by ASTM International for dried hemp. Full article
(This article belongs to the Special Issue Method Development and Validation in Food and Pharmaceutical Analysis IV)
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Graphical abstract

23 pages, 4450 KiB  
Article
Quality Evaluation of Peony Petals Based on the Chromatographic Fingerprints and Simultaneous Determination of Sixteen Bioactive Constituents Using UPLC-DAD-MS/MS
by Zhining Li, Yanni Ma, Feifei Li, Yue Wei, Lixian Zhang, Liqin Yu, Ling Chen, Xuefang Wang, Erjuan Ning, Lipan Zhang, Fayun Wang, Xiao Li, Chun Chang and Yi Fan
Molecules 2023, 28(23), 7741; https://doi.org/10.3390/molecules28237741 - 24 Nov 2023
Viewed by 1246
Abstract
In this study, a validated quality evaluation method with peony flower fingerprint chromatogram combined with simultaneous determination of sixteen bioactive constituents was established using UPLC-DAD-MS/MS. The results demonstrated that the method was stable, reliable, and accurate. The UPLC chemical fingerprints of 12 different [...] Read more.
In this study, a validated quality evaluation method with peony flower fingerprint chromatogram combined with simultaneous determination of sixteen bioactive constituents was established using UPLC-DAD-MS/MS. The results demonstrated that the method was stable, reliable, and accurate. The UPLC chemical fingerprints of 12 different varieties of peonies were established and comprehensively evaluated by similarity evaluation (SE), hierarchical cluster analysis (HCA), principal component analysis (PCA), and quantification analysis. The results of SE indicated that similar chemical components were present in these samples regardless of variety, but there were significant differences in the content of chemical components and material basis characteristics. The results of HCA and PCA showed that 12 varieties of samples were divided into two groups. Four flavonoids (11, 12, 13, and 16), five monoterpenes and their glycosides (3, 4, 6, 14, and 15), three tannins (7, 9, and 10), three phenolic acids (1, 2, and 5), and one aromatic acid (8) were identified from sixteen common peaks by standards and liquid chromatography–mass spectrometry (LC–MS). The simultaneous quantification of six types of components was conducted with the 12 samples, it was found that the sum contents of analytes varied obviously for peony flower samples from different varieties. The content of flavonoids, tannins, and monoterpenes (≥19.34 mg/g) was the highest, accounting for more than 78.45% of the total compounds. The results showed that the flavonoids, tannins, and monoterpenes were considered to be the key indexes in the classification and quality assessment of peony flower. The UPLC-DAD-MS/MS method coupled with multiple compounds determination and fingerprint analysis can be effectively applied as a feature distinguishing method to evaluate the compounds in peony flower raw material for product quality assurance in the food, pharmaceutical, and cosmetic industries. Moreover, this study provides ideas for future research and the improvement of products by these industries. Full article
(This article belongs to the Special Issue Method Development and Validation in Food and Pharmaceutical Analysis IV)
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