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Various Methods for Pharmaceutical Analysis Processes

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

Deadline for manuscript submissions: closed (30 June 2024) | Viewed by 8252

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Prof. Dr. Ki-Jung Paeng

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Guest Editor

Department of Chemistry, Yonsei University, Yonseidae-gil 1, Wonju 26493, Republic of Korea
Interests: GC/MS; LC/MS; sample preparation; SPE; chemical sensors; spectroscopies analytical chemistry
Special Issues, Collections and Topics in MDPI journals

Prof. Dr. Jongki Hong

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Guest Editor

College of Pharmacy, Kyung Hee University, Metabolomics Research Lab, Seoul 02447, Republic of Korea
Interests: metabolomics based on mass spectrometry combined with GC and LC; drug sceening in pharmaceuticals

Special Issue Information

Dear Colleagues,

We cordially invite manuscript submissions on the topic of "Various Methods for Pharmaceutical Analysis Processes". This Special Issue aims to bring together innovative research works that showcase novel techniques and approaches in pharmaceutical analysis.

Pharmaceutical analysis is a critical component of the drug development process, as it ensures the quality, safety, and efficacy of pharmaceutical products. In recent years, various analytical methods have been developed to address the increasing complexity of drug formulations and the need for more accurate and sensitive analysis.

We welcome original research articles, reviews, and short communications that cover different aspects of pharmaceutical analysis, including, but not limited to:

Chromatographic and spectroscopic methods;
Electrochemical and immunochemical methods;
Sample preparation and separation techniques;
Quality control and validation methods;
Pharmacokinetic and pharmacodynamic studies;
Drug impurity profiling and stability testing.

All manuscripts will be subject to rigorous peer review to ensure high-quality publications. Accepted articles will be published in a Special Issue in our journal, which will be widely disseminated to the scientific community.

We look forward to your contributions and thank you for considering our invitation.

Prof. Dr. Ki-Jung Paeng
Prof. Dr. Jongki Hong
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

analytical method
pharmaceutical analysis
drug impurity profiling
stability testing

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Published Papers (4 papers)

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Research

13 pages, 4743 KiB

Open AccessArticle

¹¹B NMR of the Morphological Evolution of Traditional Chinese Medicine Borax

by Qiulin Li, Yawen Yang, Qingfeng Wang, Xiang Han, Junfeng Zhu, Nan Zhang, Qiuhong Wang, Kanshe Li, Pin Gong and Fuxin Chen

Molecules 2024, 29(1), 251; https://doi.org/10.3390/molecules29010251 - 3 Jan 2024

Cited by 1 | Viewed by 1867

Abstract

This article applies nuclear magnetic resonance technology to the study of boron-containing traditional Chinese medicine, in order to explore the morphological evolution of boron elements in traditional Chinese medicine. Borax is a traditional Chinese medicine with anti-corrosion, anti-inflammatory, antibacterial, and anticonvulsant effects. It is made by boiling, removing stones, and drying borax minerals like borate salts. This article introduces an ¹¹B nuclear magnetic resonance method for identifying and characterizing boron-containing compounds in TCM. We applied this technology to borax aqueous solutions in different chemical environments and found that with boron mixed in the form of SP² hybridization in equilateral triangles and SP³ hybridization in equilateral tetrahedra, the pH changes in alkaline environments significantly affected the ratio of the two. At the same time, it was found that in addition to the raw material peak, boron signals of other boron-containing compounds were also detected in 20 commercially available boron-containing TCM preparations. These new boron-containing compounds may be true pharmaceutical active ingredients, and adding them directly to the formula can improve quality and safety. This article describes the detection of ¹¹B NMR in boron-containing traditional Chinese medicine preparations. It is simple, non-destructive, and can provide chemical fingerprint studies for boron-containing traditional Chinese medicine. Full article

(This article belongs to the Special Issue Various Methods for Pharmaceutical Analysis Processes)

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15 pages, 1971 KiB

Open AccessArticle

Development and Validation of LC-MS/MS Method for the Determination of 1-Methyl-4-Nitrosopiperazine (MNP) in Multicomponent Products with Rifampicin—Analytical Challenges and Degradation Studies

by Anna B. Witkowska, Aleksandra Wołczyńska, Agnieszka Lis-Cieplak and Elżbieta U. Stolarczyk

Molecules 2023, 28(21), 7405; https://doi.org/10.3390/molecules28217405 - 3 Nov 2023

Cited by 3 | Viewed by 3054

Abstract

Rifampicin is an essential medicine for treating and preventing tuberculosis (TB). TB is a life-threatening infectious disease and its prevention and treatment are public health imperatives. In the time of a global crisis of nitrosamine contamination of medicinal products, patient safety and a reduction in the number of drug recalls at the same time are crucial. In this work, the LC-MS/MS method was developed for the determination of the 1-methyl-4-nitrosospiperazine (MNP), a genotoxic nitrosamine impurity in various products containing rifampicin at a 5.0 ppm limit level according to Food and Drug Administration (FDA). Extraction with neutralization was necessary due to the matrix and solvent effect associated with the complexity of the rifampicin product. The developed method was validated in accordance with regulatory guidelines. Specificity, accuracy, precision, limit of detection, and limit of quantification parameters were evaluated. The recovery of the MNP was 100.38 ± 3.24% and the intermediate precision was 2.52%. The contamination of MNP in Rifampicin originates in the manufacturing process of the drug. Furthermore, the results of the forced degradation experiments show that the formation of MNP is possible by two mechanisms: through degradation of rifampicin and the oxidation of 1-amino-4-methyl-piperazine. This article points out that it is necessary to monitor and describe degradation products and the mechanism of degradation of potentially affected active pharmaceutical ingredient (API) with respect to the formation of nitrosamines during stress testing, as it was done in the following work for rifampicin in multicomponent products. Full article

(This article belongs to the Special Issue Various Methods for Pharmaceutical Analysis Processes)

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12 pages, 864 KiB

Open AccessArticle

Uncertainty Evaluation for the Quantification of Urinary Amphetamine and 4-Hydroxyamphetamine Using Liquid Chromatography–Tandem Mass Spectrometry: Comparison of the Guide to the Expression of Uncertainty in Measurement Approach and the Monte Carlo Method with R

by Seon Yeong Kim, Dong Won Shin, Jihye Hyun, Nam Hee Kwon, Jae Chul Cheong, Ki-Jung Paeng, Jooyoung Lee and Jin Young Kim

Molecules 2023, 28(19), 6803; https://doi.org/10.3390/molecules28196803 - 25 Sep 2023

Viewed by 1298

Abstract

Estimating the measurement uncertainty (MU) is becoming increasingly mandatory in analytical toxicology. This study evaluates the uncertainty in the quantitative determination of urinary amphetamine (AP) and 4-hydroxyamphetamine (4HA) using a liquid chromatography–tandem mass spectrometry (LC–MS/MS) method based on the dilute-and-shoot approach. Urine sample dilution, preparation of calibrators, calibration curve, and method repeatability were identified as the sources of uncertainty. To evaluate the MU, the Guide to the Expression of Uncertainty in Measurement (GUM) approach and the Monte Carlo method (MCM) were compared using the R programming language. The MCM afforded a smaller coverage interval for both AP (94.83, 104.74) and 4HA (10.52, 12.14) than that produced by the GUM (AP (92.06, 107.41) and 4HA (10.21, 12.45)). The GUM approach offers an underestimated coverage interval for Type A evaluation, whereas the MCM provides an exact coverage interval under an abnormal probability distribution of the measurand. The MCM is useful in complex settings where the measurand is combined with numerous distributions because it is generated from the uncertainties of input quantities based on the propagation of the distribution. Therefore, the MCM is more practical than the GUM for evaluating the MU of urinary AP and 4HA concentrations using LC–MS/MS. Full article

(This article belongs to the Special Issue Various Methods for Pharmaceutical Analysis Processes)

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11 pages, 2577 KiB

Open AccessArticle

An Automated Solid-Phase Extraction–UPLC–MS/MS Method for Simultaneous Determination of Sulfonamide Antimicrobials in Environmental Water

by Mengyu Qi, Pengfei He, Hongmei Hu, Tongtong Zhang, Tiejun Li, Xiaoning Zhang, Yilin Qin, Yingjie Zhu and Yuanming Guo

Molecules 2023, 28(12), 4694; https://doi.org/10.3390/molecules28124694 - 11 Jun 2023

Cited by 6 | Viewed by 1641

Abstract

The large-scale use of sulfonamide antimicrobials in human and veterinary medicine has seriously endangered the ecological environment and human health. The objective of this study was to develop and validate a simple and robust method for the simultaneous determination of seventeen sulfonamides in water using ultra-high performance liquid chromatography–tandem mass spectrometry coupled with fully automated solid-phase extraction. Seventeen isotope-labeled internal standards for sulfonamides were used to correct matrix effects. Several parameters affecting extraction efficiency were systematically optimized, and the enrichment factors were up to 982−1033 and only requiring about 60 min per six samples. Under the optimized conditions, this method manifested good linearity (0.05–100 μg/L), high sensitivity (detection limits: 0.01–0.05 ng/L), and satisfactory recoveries (79–118%) with acceptable relative standard deviations (0.3–14.5%, n = 5). The developed method can be successfully utilized for the determination of 17 sulfonamides in pure water, tap water, river water, and seawater. In total, six and seven sulfonamides were detected in river water and seawater, respectively, with a total concentration of 8.157–29.676 ng/L and 1.683–36.955 ng/L, respectively, and sulfamethoxazole was the predominant congener. Full article

(This article belongs to the Special Issue Various Methods for Pharmaceutical Analysis Processes)

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