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Analysis of institutional authors

Lorenzo, Ma PazAuthorAguilar-Ros, AntonioCorresponding Author

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June 7, 2022
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Development and validation of a HPLC-UV method for methadone hydrochloride quantification in a new oral solution with preservatives to be implemented in physicochemical stability studies

Publicated to: Bmc Chemistry. 16 (1): 32- - 2022-05-14 16(1), DOI: 10.1186/s13065-022-00827-9

Authors:

Alvaro-Alonso, EA; Lorenzo, MP; Escobar-Rodríguez, I; Aguilar-Ros, A
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Affiliations

Infanta Leonor Univ Hosp, Pharm Dept, Av Gran Via Este 80, Madrid 28031, Spain - Author
Univ CEU San Pablo, CEU Univ, Fac Farm, Boadilla De Monte 28660, Spain - Author
Univ CEU San Pablo, CEU Univ, Fac Farm, Ctr Metabol & Bioanal CEMBIO, Boadilla Del Monte 28660, Spain - Author
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Abstract

Purpose: The Pharmacy Service of the Infanta Leonor University Hospital acquires, compounds, distributes and dispenses more than 3000 L of methadone oral solution to Drug Addiction Patients Centers per year. Our purpose is to develop and validate an improved high performance liquid chromatography (HPLC) method to quantify methadone hydrochloride in a new oral solution with methylhydroxybenzoate (methylparaben) and propylhydroxybenzoate (propylparaben) to be implemented in physicochemical stability studies that allow to provide more information and even to increase the beyond-use date.Methods: A HPLC-Agilent (R) 1100 equipment, comprising a quaternary pump and an ultraviolet diode-array-detector (DAD) was used. An analytical method development and validation was completed. The curve was constructed from methadone working concentrations of 75-125% (7.5, 9.0, 10.0, 11.0 and 12.5 mg/mL) to assess the linear relationship between the concentration of the analyte and the obtained areas. Precision and accuracy were calculated. Detection and quantification limit (LD, LQ) were estimated using the EURACHEM method. Forced-degradation studies were also performed.Results: Chromatographic conditions were: flow rate 1.6 mL/min; mobile phase 55% acetonitrile and 45% sodium phosphate 25 mM (pH = 10); injection volume was 5 mu L. The column was a Waters-XTerra (TM) RP18, maintained at 40 degrees C. DAD was lambda=254 nm. Retention times for methadone, methylparaben and propylparaben were 4.34, 0.70 and 0.88 min respectively.The method was linear (y= 284.3x - 97.8, r=0.996). Instrumental precision was 0.33% for standards (n=10); intra-assay precision 0.53% (n = 6) and inter-assay precision 1.95% (n = 12). The relative standard deviation percentage for accuracy was 1.28%. The recovery percentage was 101.5 +/- 1.5%. LQ and LD were 2.18 mu g/mL and 2.0 mu g/mL respectively. The most destabilizing conditions were oxidizing and alkaline. The chromatograms confirmed no interference with the methadone signal.Conclusions: The HPLC method has proved to be valid and reproducible for methadone quantification in a new oral solution with methylparaben and propylparaben. This assay is a rapid, simple and reliable technique that can be used in daily analysis and physicochemical stability studies.
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Keywords

analysisanalytical chemistry methoddrug compoundinghigh performance liquid chromatographymethadone hydrochlorideAnalysisAnalytical chemistry methodDrug compoundingExtractionHigh performance liquid chromatographyIllicit drugsInjectionLiquid-chromatographic analysisMetabolitesMethadone hydrochloridePharmaceutical solutionsQuantitative-determinationWaste-water

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Bmc Chemistry due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position 63/178, thus managing to position itself as a Q2 (Segundo Cuartil), in the category Chemistry, Multidisciplinary. Notably, the journal is positioned en el Cuartil Q2 para la agencia Scopus (SJR) en la categoría Chemistry (Miscellaneous).

Independientemente del impacto esperado determinado por el canal de difusión, es importante destacar el impacto real observado de la propia aportación.

Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2026-01-20:

  • WoS: 4
  • Scopus: 6
  • Europe PMC: 2
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Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2026-01-20:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 12.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 12 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 7.
  • The number of mentions on the social network X (formerly Twitter): 8 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
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Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: Last Author (AGUILAR ROS, ANTONIO).

the author responsible for correspondence tasks has been AGUILAR ROS, ANTONIO.

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Awards linked to the item

We would like to acknowledge the entire CEMBIO department of the San Pablo Ceu University Faculty of Pharmacy for allowing us to use their material, facilities and equipment to carry out this work. We also want to thank the Subdirectorate of Pharmacy and Health Products and the Subdirection of Addictions of the Ministry of Health of the Autonomous Community of Madrid for the collaboration and support always received. All these entities have helped develop this Project and bring it to fruition. For their unqualified and total support, we extend special thanks to the Direction of the Infanta Leonor University Hospital, the Pharmacy Service, and other Central Services of the Infanta Leonor University Hospital. We would also like to thank Brian Crilly Montagne, Maria Chuecos Lozano and Francisco Javier Ruperez Pascualena for the editorial help in the preparation of this paper.
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