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Advances in Pharmaceutical Analytical Technologies

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

Deadline for manuscript submissions: 30 April 2024 | Viewed by 5841

Special Issue Editor

Dr. Alexis Oliva

E-Mail Website
Guest Editor
Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, 38001 Tenerife, Spain
Interests: pharmaceutical; HPLC; analytical method; quality by design; design of experiments; validation; development and optimization; quality-control samples
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The use of analytical tools to determine pharmaceutical drugs for the rapid diagnosis of diseases is mandatory for every laboratory working in the field of bioanalysis. In the last few years, the development of new analytical technologies has widened the scope of application of such techniques to several areas, for instance, the development of new therapeutic agents and broader industries, alongside others.

Once the analytic method is selected, the next step consists of its development and optimization before validation. At present, the idea and principles of quality by design (QbD) are applied to the development of analytic methods. This type of study involves using the design of experiments (DoE) and multiple linear regressions (MLR) strategies. After the satisfactory development and optimization of an analytic method, it must be validated to demonstrate suitability for an intended purpose. For this, it can be assessed with two methods and aims: (i) “pre-study” validation, to demonstrate that it is able to provide appropriate accuracy and precision; (ii) “in-study” validation to verify whether the method remains valid over time. This is conducted by inserting quality control samples and through the use of control charts.

Presenting a very broad scope, this Special Issue welcomes full papers, short communications, and review articles on, but not limited to, new developments in bioanalysis, sample preparation, and the development and quantification of pharmaceuticals in complex matrices or in biological samples with applications in different analytical fields.

Dr. Alexis Oliva
Guest Editor

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

  • pharmaceutical
  • quality by design
  • design of experiments
  • analytical method
  • validation
  • development and optimization
  • quality control samples

Published Papers (5 papers)

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Research

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11 pages, 1771 KiB  
Article
Study of Bitespiramycin Distribution in Rats and Cerebrospinal Fluid of Patients by a Sensitive LC-MS/MS Method with Rapid Sample Preparation
by Yujie Zhang, Jingjie Cao, Jiahan Su, Tingting He, Qianru Wang, Feng Wei, Xin Guo, Qibing Mei and Jing Zeng
Molecules 2024, 29(5), 1037; https://doi.org/10.3390/molecules29051037 - 28 Feb 2024
Viewed by 450
Abstract
Bitespiramycin, has been shown to have a therapeutic effect against respiratory tract inflammation, including a potential effect against COVID-19. A current clinical trial in China showed that bitespiramycin was an effective treatment for severe pneumonia and intracranial infection. However, there is lack of [...] Read more.
Bitespiramycin, has been shown to have a therapeutic effect against respiratory tract inflammation, including a potential effect against COVID-19. A current clinical trial in China showed that bitespiramycin was an effective treatment for severe pneumonia and intracranial infection. However, there is lack of an analytical method to elucidate the distribution of bitespiramycin. In this study, a highly sensitive, rapid and reliable UPLC–MS/MS method was developed to comprehensively characterize the bitespiramycin distribution in various bio-samples, which is significantly improved upon the published work. A rapid sample preparation method was developed by using n-butanol as the solvent to extract bitespiramycin from different bio-samples. The extract was then directly analyzed by UPLC–MS/MS coupled with an alkaline-resistant column after centrifugation which avoids the time-consuming concentration process under nitrogen and redissolution. The method was employed to accurately quantify bitespiramycin and its metabolites in rat plasma, tissues, and human cerebrospinal fluid. Notably, the presence of bitespiramycin and its metabolites was identified for the first time in various rat organs including brain, testis, bladder and prostate as well as in human cerebrospinal fluid. This newly developed approach shows great promise for drug distribution assays including other antibiotics and can help elucidate the ADME of bitespiramycin. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Analytical Technologies)
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13 pages, 1031 KiB  
Article
Ultrasound-Assisted Extraction, Followed by Gas Chromatography–Mass Spectrometry for the Simultaneous Quantification of Ethinyl Estradiol and Drospirenone in Contraceptive Formulations
by Javier Peña, Iria González-Mariño and José L. Pérez Pavón
Molecules 2023, 28(13), 4978; https://doi.org/10.3390/molecules28134978 - 25 Jun 2023
Viewed by 953
Abstract
Contraceptive tablets typically contain a combination of two synthetic versions of an estrogen and a progestogen, which work together to inhibit the ovulation process. An accurate and precise quantification of these components is essential for contraceptive producers. In this study, we have developed [...] Read more.
Contraceptive tablets typically contain a combination of two synthetic versions of an estrogen and a progestogen, which work together to inhibit the ovulation process. An accurate and precise quantification of these components is essential for contraceptive producers. In this study, we have developed the first gas chromatography–mass spectrometry (GC–MS) method for the simultaneous quantification of 17α-ethinyl estradiol (EE) and drospirenone (DP) in contraceptive formulations. Under the final working conditions, analytes were extracted from the solid by ultrasound-assisted extraction (15 min) in methanol. The resulting suspension was diluted in ethyl acetate, subjected to centrifugation and, finally, the supernatant was directly injected into the GC–MS system. No derivatization reagents were utilized. To correct for instrumental variations, calibration was performed using the internal standard method, with cholesterol as the internal standard. A good linearity was achieved throughout the calibration range for both EE (3–12 µg mL−1) and DP (300–1200 µg mL−1), with R2 values exceeding 0.99. Trueness, assessed in terms of percentages of recovery, was also found to be satisfactory for both analytes, with recovery rates of 106 ± 8% for EE and 93 ± 9% for DP. Furthermore, intra-day and inter-day precision studies yielded relative standard deviation values below 6% for both analytes. In terms of sensitivity, the instrumental limits of detection were 0.25 µg mL−1 for EE and 6.6 µg mL−1 for DP, and the instrumental limits of quantification 0.82 µg mL−1 for EE and 22 µg mL−1 for DP. The method was successfully applied to the analysis of contraceptive tablets from three different pharmaceutical companies. No differences were observed between the measured and the declared amount of active principle per tablet, demonstrating the applicability of the procedure. In addition, a stability study conducted on both the standards and sample extracts demonstrated that they can be stored at room temperature for a minimum period of seven days. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Analytical Technologies)
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12 pages, 1977 KiB  
Article
Multi-Detection Size Exclusion Chromatography as an Advanced Tool for Monitoring Enzyme–Antibody Conjugation Reaction and Quality Control of a Final Product
by Adela Štimac, Tihana Kurtović and Beata Halassy
Molecules 2023, 28(11), 4567; https://doi.org/10.3390/molecules28114567 - 05 Jun 2023
Viewed by 1635
Abstract
The multi-detection size exclusion chromatography (SEC) has been recognized as an advanced analytical technique for the characterization of macromolecules and process control, as well as the manufacturing and formulation of biotechnology products. It reveals reproducible molecular characterization data, such as molecular weight and [...] Read more.
The multi-detection size exclusion chromatography (SEC) has been recognized as an advanced analytical technique for the characterization of macromolecules and process control, as well as the manufacturing and formulation of biotechnology products. It reveals reproducible molecular characterization data, such as molecular weight and its distribution, and the size, shape, and composition of the sample peaks. The aim of this work was to investigate the potential and suitability of the multi-detection SEC as a tool for surveillance over the molecular processes during the conjugation reaction between the antibody (IgG) and horseradish peroxidase (HRP), and demonstrate the plausibility of its application in the quality control of the final product, the IgG-HRP conjugate. Guinea pig anti-Vero IgG-HRP conjugate was prepared using a modified periodate oxidation method, based on periodate oxidation of the carbohydrate side chains of HRP, followed by the formation of Schiff bases between the activated HRP and amino groups of the IgG. The quantitative molecular characterization data of the starting samples, intermediates, and final product were obtained by multi-detection SEC. Titration of the prepared conjugate was performed by the ELISA and its optimal working dilution was determined. This methodology proved to be a promising and powerful technology for the IgG-HRP conjugate process control and development, as well as for the quality control of the final product, as verified by the analysis of several commercially available reagents. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Analytical Technologies)
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14 pages, 2286 KiB  
Article
Development and Validation of Green and High-Throughput Microwell Spectrophotometric Assay for the Determination of Selective Serotonin Reuptake Inhibitors in Their Pharmaceutical Dosage Forms
by Ibrahim A. Darwish and Nourah Z. Alzoman
Molecules 2023, 28(10), 4221; https://doi.org/10.3390/molecules28104221 - 21 May 2023
Cited by 5 | Viewed by 1086
Abstract
This study describes the development and validation of a new green and high-throughput microwell spectrophotometric assay (MW-SPA) for the determination of three selective serotonin reuptake inhibitors (SSRIs) in their pharmaceutical dosage forms. These SSRIs are fluoxetine, fluvoxamine, and paroxetine, the most prescribed drugs [...] Read more.
This study describes the development and validation of a new green and high-throughput microwell spectrophotometric assay (MW-SPA) for the determination of three selective serotonin reuptake inhibitors (SSRIs) in their pharmaceutical dosage forms. These SSRIs are fluoxetine, fluvoxamine, and paroxetine, the most prescribed drugs for the treatment of depression. The proposed assay was based on the formation of orange-colored N-substituted naphthoquinone derivatives upon the reaction of SSRIs with 1,2-naphthoquinone-4-sulphonate (NQS) in alkaline media. The assay was conducted in 96-microwell assay plates, and the absorbances of the reaction products were measured by a microplate reader at their maximum absorbance wavelengths. The optimum conditions of the reaction were refined and established. Under these conditions, calibration curves were generated, and linear regression equations were computed. The linear relations between the absorbances and drug concentrations were linear with good correlation coefficients (0.9992–0.9997) in the range of 2–80 µg/mL. The assay limits of detection were in the range of 1.5–4.2 µg/mL. The precision was satisfactory as the values of relative standard deviation did not exceed 1.70%. The accuracy of the assay was ≥98.2%. The proposed MW-SPA was successfully applied to the analysis of the SSRIs in their pharmaceutical dosage forms with acceptable accuracy and precision; the label claims were 99.2–100.5% (±0.96–1.35%). The results of the proposed MW-SPA were compared with those of the official/pre-validated assays by statistical analysis with respect to the accuracy (by t-test) and precision (by F-test). No significant differences were found between the calculated and theoretical values of the t- and F-tests at the 95% confidence level, proving similar accuracy and precision in the determination of SSRIs by both assays. The greenness of the proposed assay was confirmed by two metric tools. In addition, the assay is characterized with a high-throughput property which enables the simultaneous analysis of many samples in a short time. Therefore, the assay is a valuable tool for rapid routine application in pharmaceutical quality control units for the determination of the investigated SSRIs. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Analytical Technologies)
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Review

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13 pages, 1500 KiB  
Review
Research Progress of Ferula ferulaeoides: A Review
by Zhengqiong Chen, Gang Zhou and Shengjun Ma
Molecules 2023, 28(8), 3579; https://doi.org/10.3390/molecules28083579 - 19 Apr 2023
Cited by 2 | Viewed by 1226
Abstract
Ferula ferulaeoides (Steud.) Korov is one of the traditional ethnic medicines in Xinjiang Uygur and Kazakh of China, which mainly contains volatile oils, terpenoids, coumarins and other chemical components. Previous work has shown that F. ferulaeoides exhibited insecticide, antibacterial, antitumor properties, and so [...] Read more.
Ferula ferulaeoides (Steud.) Korov is one of the traditional ethnic medicines in Xinjiang Uygur and Kazakh of China, which mainly contains volatile oils, terpenoids, coumarins and other chemical components. Previous work has shown that F. ferulaeoides exhibited insecticide, antibacterial, antitumor properties, and so on. In this paper, the chemical composition, pharmacological activity, and quality control of F. ferulaeoides were reviewed, and the application of F. ferulaeoides in the food industry was explored, so as to provide some reference for the quality evaluation of F. ferulaeoides and its further development and utilization. Full article
(This article belongs to the Special Issue Advances in Pharmaceutical Analytical Technologies)
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