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Processes
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Pharmaceutical and Biomedical Analysis
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Pharmaceutical and Biomedical Analysis

A special issue of Processes (ISSN 2227-9717). This special issue belongs to the section "Pharmaceutical Processes".

Deadline for manuscript submissions: closed (10 March 2022) | Viewed by 12940

Special Issue Editors

Dr. Hsiao-Wei Liao

E-Mail Website
Guest Editor
Faculty of Pharmacy, National Yang-Ming University, Taipei 11221, Taiwan
Interests: liquid chromatography; capillary electrophoresis; mass spectrometry; pharmaceutical analysis; metabolomics; lipidomics
Special Issues, Collections and Topics in MDPI journals
Dr. Guan-Yuan Chen

E-Mail Website
Guest Editor
Graduate Institute of Forensic Medicine, National Taiwan University, Taipei 10617, Taiwan
Interests: metabolomics; mass spectrometry analysis; pharmaceutical analysis; therapeutic drug monitoring (TDM); forensic toxicology; chemical isotope labeling (CIL); automation

Special Issue Information

Dear Colleagues,

We invite you to make submissions to this Special Issue of Processes focused on “Pharmaceutical and Biomedical Analysis”. The development of reliable analytical strategy is always an important mission for pharmaceutical and biomedical analysis. With the progression of analytical techniques in sample pretreatment, separation science, and detection technology, analytical methods would be more beneficial for pharmaceutical and biomedical researchers to ensure the quality of pharmaceutical products, quantify and/or discover substances in complicated biological samples, determine biomolecules to reveal biological mechanisms behind metabolic networks. Using innovative analytical approaches with state-of-the-art analytical instruments, such as liquid chromatography (LC), gas chromatography (GC), capillary electrophoresis (CE), and mass spectrometry (MS) for novel applications can accelerate pharmaceutical and biomedical researches in the future. 

This Special Issue seeks novel research contributions in, but not limited to, the following areas:

  • Development of innovative analytical methods for pharmaceuticals and biomolecules
  • Pharmaceutical analysis for drug safety and therapeutic drug monitoring (TDM)
  • Biomedical analysis for omic science and translational medicine

We welcome and look forward to your submissions.

Dr. Hsiao-Wei Liao
Dr. Guan-Yuan Chen
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. Processes is an international peer-reviewed open access monthly 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 2400 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

  • separation technology
  • mass spectrometry
  • pharmaceutical analysis
  • omics sciences
  • biomedical analysis
  • sampling methods
  • automation

Published Papers (5 papers)

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Research

15 pages, 1508 KiB  
Article
UPLC-MS/MS-Based Analysis of Trastuzumab in Plasma Samples: Application in Breast Cancer Patients Sample Monitoring
by Aadil Ahmad Sheikh, Ozair Alam, Rehan Abdur Rub, Muzaffar Iqbal, Kunjahari Medhi, Abdulkhaliq J. Alsalman, Mohd Imran, Sultan Alshehri, Mohammed M. Ghoneim and Faiyaz Shakeel
Processes 2022, 10(3), 509; https://0-doi-org.brum.beds.ac.uk/10.3390/pr10030509 - 03 Mar 2022
Viewed by 2602
Abstract
Trastuzumab is a target-based recombinant humanized IgG1 monoclonal antibody (mAbs), extensively employed for treatment of metastatic breast cancer with human epidermal growth receptor 2 (HER2) overexpression. Studies around the world have reported that mAbs have substantial inter-patient unpredictable absorption, distribution, metabolism, and excretion [...] Read more.
Trastuzumab is a target-based recombinant humanized IgG1 monoclonal antibody (mAbs), extensively employed for treatment of metastatic breast cancer with human epidermal growth receptor 2 (HER2) overexpression. Studies around the world have reported that mAbs have substantial inter-patient unpredictable absorption, distribution, metabolism, and excretion (ADME-pharmacokinetics) because of multiple elements manipulating the concentration of mAbs in plasma. Herein, we have established a bioanalytical technique using UPLC-MS/MS with an easy sample workup method and in-solution digestion protocol to assay the trastuzumab plasma samples from breast cancer patients in clinical studies. Surrogated proteolytic peptides were used for accurate quantification of trastuzumab (CanMab) with a trastuzumab signature peptide with [13C6, 15N4]-arginine and [13C6, 15N2]-lysine stable isotope-labeled (SIL) peptide. Experiments to validate the method were accurately carried out according to the guidelines mentioned in the bioanalytical method validation protocol. The evaluation established excellent linearity over a wide range of 5–500 µg/mL. The experimental procedure was efficaciously performed in a pilot study of five breast cancer patients and residual concentrations of drugs from responding and non-responding subjects were compared. The receiver operating characteristic (ROC) examination displayed that 52.25 µg/mL was the Cmin threshold predictive response with a satisfactory sensitivity of 88.58% and specificity of 79.25%. Full article
(This article belongs to the Special Issue Pharmaceutical and Biomedical Analysis)
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10 pages, 983 KiB  
Article
Isolation and Analytical Method Validation for Phytocomponents of Aqueous Leaf Extracts from Vaccinium bracteatum Thunb. in Korea
by Seul-Gi Lee, Haeju Ko, Eun-Jin Choi, Dool-Ri Oh, Donghyuck Bae and Chulyung Choi
Processes 2021, 9(11), 1868; https://0-doi-org.brum.beds.ac.uk/10.3390/pr9111868 - 20 Oct 2021
Viewed by 1647
Abstract
In this study, major phytochemical compounds of Vaccinium bracteatum Thunb. (VB) aqueous leaf extract were isolated and analyzed using a HPLC-based method, followed by method validation in accordance with the International Conference on Harmonisation (ICH) guidelines for drug development. Five major compounds were [...] Read more.
In this study, major phytochemical compounds of Vaccinium bracteatum Thunb. (VB) aqueous leaf extract were isolated and analyzed using a HPLC-based method, followed by method validation in accordance with the International Conference on Harmonisation (ICH) guidelines for drug development. Five major compounds were isolated in VB extract. Apart from vaccinoside, which had been the only compound isolated in VB extract to date, vanillic acid and protocatechuic acid were isolated for the first time. Isolation of orientin and isoorientin in the VB extract helped validate the reverse-phase analytical method. A new simple and rapid high-performance liquid chromatography (HPLC)-based method was developed for the validation of orientin and isoorientin in VB extract and was determinated according to the ICH guidelines. The analytical method was validated through a Waters Alliance HPLC System containing an e2695 separation module and a 2998 photodiode array (PDA) detector. The VB extract and solutions of orientin and isoorientin were analyzed using a reverse-phase Eclipse XDB-C18 column (4.6 × 250 mm ID, 5 µm, Waters), which was maintained at 30 °C. A mobile phase of methanol and 0.01% formic acid in water was used at a flow rate of 1.0 mL/min to achieve gradient elution. The linearity of the orientin and isoorientin was excellent results (R2 ≥ 0.9999) in the concentration range of 1.0–50.0 μg/mL. Precision values ranged 98.55–101.70% and 98.70–101.18%, respectively. The intra-day and inter-day relative standard deviation (RSD) values of the orientin and isoorientin were all <2.0%. The average recoveries of orientin ranged 98.30–101.57%, whereas isoorientin ranged 97.81–102.14% with RSD values <2.0%. Quantitative analysis found that VB extract contained 2.90 mg/g of orientin and 3.45 mg/g of isoorientin. Full article
(This article belongs to the Special Issue Pharmaceutical and Biomedical Analysis)
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15 pages, 1035 KiB  
Article
Rapid, Sensitive, and Sustainable Reversed-Phase HPTLC Method in Comparison to the Normal-Phase HPTLC for the Determination of Pterostilbene in Capsule Dosage Form
by Prawez Alam, Faiyaz Shakeel, Mohammed H. Alqarni, Ahmed I. Foudah, Md. Faiyazuddin and Sultan Alshehri
Processes 2021, 9(8), 1305; https://0-doi-org.brum.beds.ac.uk/10.3390/pr9081305 - 28 Jul 2021
Cited by 9 | Viewed by 2240
Abstract
The greenness evaluation of literature analytical methods for pterostilbene (PT) analysis was not performed. Accordingly, the rapid, sensitive, and green/sustainable reversed-phase high-performance thin-layer chromatography (RP-HPTLC) method was developed and compared to the normal-phase (NP)-HPTLC (NP-HPTLC) for the estimation of PT with a classical [...] Read more.
The greenness evaluation of literature analytical methods for pterostilbene (PT) analysis was not performed. Accordingly, the rapid, sensitive, and green/sustainable reversed-phase high-performance thin-layer chromatography (RP-HPTLC) method was developed and compared to the normal-phase (NP)-HPTLC (NP-HPTLC) for the estimation of PT with a classical univariate calibration. The RP quantification of PT was performed using green solvent systems; however, the NP analysis of PT was performed using routine solvent systems. The PT was detected at 302 nm for both of the methods. The greenness scores for the current analytical assays were evaluated by the analytical GREEnness (AGREE) metric approach. The classical univariate calibration for RP and NP methods indicated the linearity range as 10–1600 and 30–400 ng band−1, respectively. The RP method was more reliable for PT analysis compared to the NP method. The PT contents in commercial capsule dosage form were found to be 100.84% using the RP method; however, the PT contents in commercial capsule dosage form were determined as 92.59% using the NP method. The AGREE scores for RP and NP methods were 0.78 and 0.46, respectively. The sustainable RP-HPTLC assay was able to detect PT in the presence of its degradation products, and hence it can be considered as a selective and stability-indicating method. Accordingly, the RP-HPTLC method with univariate calibration has been considered as a superior method over the NP-HPTLC method for PT analysis. Full article
(This article belongs to the Special Issue Pharmaceutical and Biomedical Analysis)
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11 pages, 939 KiB  
Article
The Development of a Liquid Chromatography High-Resolution Mass Spectrometric Method for Apixaban Quantification in Dried Plasma Spots in Parallel Reaction Monitoring Mode
by Alexander Chernonosov, Liliya Aksenova and Vladimir Koval
Processes 2021, 9(3), 450; https://0-doi-org.brum.beds.ac.uk/10.3390/pr9030450 - 02 Mar 2021
Cited by 2 | Viewed by 1972
Abstract
This work aimed at developing and validating a rapid, sensitive, and robust method of liquid chromatography with high-resolution mass spectrometry (LC–HRMS) in parallel reaction monitoring (PRM) mode for apixaban quantification in dried plasma spots (DPSs) with a simple extraction procedure. A 25 µL [...] Read more.
This work aimed at developing and validating a rapid, sensitive, and robust method of liquid chromatography with high-resolution mass spectrometry (LC–HRMS) in parallel reaction monitoring (PRM) mode for apixaban quantification in dried plasma spots (DPSs) with a simple extraction procedure. A 25 µL sample of human plasma was placed onto Whatman 903 Protein Saver Cards and allowed to dry; 3.2 mm diameter disks were cut out from DPSs using a puncher, and 100 µL of a working internal standard solution was added to each sample. After this, they were vortexed on a shaker for 15 min at 800 rpm and 40 °C and quick centrifugation (10,000× g, 10 s), and then the extracts were transferred into a 300 µL vial for LC–HRMS. Data were acquired in PRM mode via detection of all target product ions with 10 ppm tolerance. Total analysis time was 5 min. The LC–HRMS method was validated for the 10–400 ng/mL range with R2 > 0.99. Within this range, intra- and interday variability of precision and accuracy was <10%, and recovery was 69.7–85.1%. Apixaban was stable after brief storage at room temperature, and at 4 °C for up to a month. The method development and validation results proved that this LC–HRMS assay of apixaban in DPSs is selective and robust. Full article
(This article belongs to the Special Issue Pharmaceutical and Biomedical Analysis)
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9 pages, 1012 KiB  
Article
Quantitative Determination of Vitamins A and E in Ointments Using Raman Spectroscopy
by Sylwester Mazurek, Kamil Pichlak and Roman Szostak
Processes 2021, 9(1), 8; https://0-doi-org.brum.beds.ac.uk/10.3390/pr9010008 - 23 Dec 2020
Cited by 3 | Viewed by 2918
Abstract
A quantitative analysis of vitamins A and E in commercial ointments containing 0.044% and 0.8% (w/w) of active pharmaceutical ingredients, respectively, was performed using partial least squares models based on FT Raman spectra. Separate calibration systems were prepared to [...] Read more.
A quantitative analysis of vitamins A and E in commercial ointments containing 0.044% and 0.8% (w/w) of active pharmaceutical ingredients, respectively, was performed using partial least squares models based on FT Raman spectra. Separate calibration systems were prepared to determine the amount of vitamin A in a petrolatum base ointment and to quantify vitamins A and E in a eucerin base one. Compositions of the laboratory-prepared and commercial samples were controlled through a principal component analysis. Relative standard errors of prediction were calculated to compare the predictive ability of the obtained regression models. For vitamin A determination, these errors were found to be in the 3.8–5.0% and 5.7–5.9% ranges for the calibration and validation data sets, respectively. In the case of vitamin E modeling, these errors amounted to 3.7% and 4.4%. On the basis of elaborated models, vitamins A and E were successfully quantified in two commercial products with recoveries in the 99–104% range. The obtained data indicate that the Raman technique allows for accurate analysis of the composition of semisolid formulations in their native state, including low dose preparations. Full article
(This article belongs to the Special Issue Pharmaceutical and Biomedical Analysis)
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