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Separations
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Development and Validation of the HPLC Method and Its Applications...
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Development and Validation of the HPLC Method and Its Applications in Pharmaceuticals

A special issue of Separations (ISSN 2297-8739). This special issue belongs to the section "Chromatographic Separations".

Deadline for manuscript submissions: closed (20 April 2023) | Viewed by 6262

Special Issue Editor

Prof. Dr. Hayam Mahmoud Lotfy

E-Mail Website
Guest Editor
1. Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt
2. Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt
Interests: electrophoresis; gel electrophoresis; chromatography; sample preparation; chemical analysis; pharmaceutical development; analytical chemistry; high-performance liquid chromatography; method validation

Special Issue Information

Dear Colleagues,

Analytical chemistry is the study of the separation, identification, and quantification of pharmaceuticals constituting one or more compounds. The rapid growth in pharmaceutical industries and the production of new formulations around the world has given rise to an inevitable demand to seek novel and systematic analytical techniques based on separation. As a consequence, analytical method development and validation have become crucial prerequisites for achieving the reliable analytical data required to support pharmaceutical development processes.

This Special Issue on “Development and Validation of the HPLC Method and Its Applications in Pharmaceuticals” will cover a wide range of topics, including but not limited to new the analytical and bioanalytical methods relevant to the separation, identification, and determination of active compounds in pharmaceuticals, pharmacokinetics, and related disciplines.

We warmly invite our colleagues to submit their original contributions to this Special Issue in order to provide recent updates regarding the analytical methods for pharmaceuticals that will be of interest to our readers. We would be delighted if you could respond to confirm your contribution and the proposed title to assist in planning the whole issue.

Prof. Dr. Hayam Mahmoud Lotfy
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. Separations 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 2600 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

  • high-performance liquid chromatography
  • method validation
  • pharmaceutical analysis
  • separation
  • identification
  • quantification
  • analytical method
  • active compounds

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (2 papers)

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Research

15 pages, 2830 KiB  
Article
A New UHPLC Analytical Method for St. John’s Wort (Hypericum perforatum) Extracts
by Lisa Wang, Afoke Ibi, Chuck Chang and Julia Solnier
Separations 2023, 10(5), 280; https://doi.org/10.3390/separations10050280 - 25 Apr 2023
Cited by 1 | Viewed by 2829
Abstract
Commonly used to treat mood disorders, St. John’s Wort (Hypericum perforatum) is a popular herb in the natural health products industry. The potency of its active ingredients can be determined using a number of different analytical methods, but it is more [...] Read more.
Commonly used to treat mood disorders, St. John’s Wort (Hypericum perforatum) is a popular herb in the natural health products industry. The potency of its active ingredients can be determined using a number of different analytical methods, but it is more widely determined using high performance liquid chromatography (HPLC). While monographs in the United States Pharmacopeia (USP) can often be relied upon for suitable analytical methods, the method proposed for determining hypericin content in St. John’s Wort products is inefficient in carrying out this purpose. This paper presents a modified new HPLC method for determining the hypericin content that can also be used for St. John’s Worts capsules and tablets by making use of purified hypericin as a chemical standard instead of oxybenzone, applying a wavelength of 588 nm during analysis and utilizing a binary instead of ternary mobile phase gradient. The resulting method and sample chromatograms provide better resolved, more easily identifiable peaks, shorter run time, and increased sustainability compared to the original USP method. This proposed method was developed using the more refined ultra-high performance liquid chromatography (UHPLC) and serves as a more accurate and reliable method for determining hypericin content in St. John’s Wort. Full article
(This article belongs to the Special Issue Development and Validation of the HPLC Method and Its Applications in Pharmaceuticals)
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13 pages, 756 KiB  
Article
RP-HPLC-Based Bioanalytical Approach for Simultaneous Quantitation of Cinnarizine and Domperidone in Rat Plasma
by Mohit Vij, Neha Dand, Lalit Kumar, Amardeep Ankalgi, Pankaj Wadhwa, Sultan Alshehri, Faiyaz Shakeel, Mohammed M. Ghoneim, Prawez Alam and Shahid Ud Din Wani
Separations 2023, 10(3), 159; https://doi.org/10.3390/separations10030159 - 25 Feb 2023
Cited by 3 | Viewed by 2602
Abstract
An accurate, precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) bioanalytical approach was developed for the simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in rat plasma using irbesartan (IRB) as an internal standard (IS). The proposed RP-HPLC approach was validated as per [...] Read more.
An accurate, precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) bioanalytical approach was developed for the simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in rat plasma using irbesartan (IRB) as an internal standard (IS). The proposed RP-HPLC approach was validated as per the latest ICH M10 guidelines. The analytes (CIN and DOM) and IS were extracted from plasma samples using the protein precipitation strategy. Chromatographic separation is accomplished by a C18 SunfireTM (5 µm, 250 mm × 4.6 mm) analytical column, using an isocratic mobile phase consisting of acetonitrile-methanol in 30:70 proportions at a flow rate of 1 mL/min. The detection of all three constituents was recorded at a wavelength of 270 nm with a UV detector. DOM, CIN and IS were eluted at 3.2, 4.5 and 6.1 min, respectively, utilizing a total run time of 10 min. The lower limit of quantification (LLOQ) was 5 ng/mL for CIN and DOM in rat plasma. The proposed RP-HPLC approach was linear in the 5–200 ng/mL range for CIN and DOM. The recovery of the method was greater than 95%, and the relative uncertainty was less than 2%, indicating that the proposed bioanalytical approach was accurate and precise. The limit of detection was established as 1.1 ng/mL for CIN and 1.7 ng/mL for DOM. The created approach was found to be robust and passed all validation criteria; thus, the proposed RP-HPLC approach can be employed successfully for the simultaneous assessment of CIN and DOM in rat plasma. Full article
(This article belongs to the Special Issue Development and Validation of the HPLC Method and Its Applications in Pharmaceuticals)
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