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A Novel Mobile Phase for Green Chromatographic Determination of Haloperidol: Application to Commercial Pharmaceutical Products and Forced Degradation Studies

Lookup NU author(s): Dr Jie ZhangORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2025 by the authors. The target molecule of this study is haloperidol, a neuroleptic from the butyrophenone family. It is one of the most widely used psychotropic drugs globally and is considered as effective as other low-potency psychotropic medications. The RP-HPLC method employed in this study utilizes a novel mobile phase composed of a 90:10 mixture of methanol and phosphate buffer (pH = 9.8) for isocratic elution. This method has been validated with a correlation coefficient (R) of 0.999 across a concentration range of 2.5 to 50 µg/mL. It exhibits excellent sensitivity, with a relative standard deviation (RSD) of less than 2% for both precision and accuracy. The method is highly effective for the analysis of haloperidol in oral commercial formulations. The mobile phase is cost-efficient, environmentally friendly, and simple to use, making it suitable for analyzing haloperidol in both liquid and powder forms. Additionally, the method is applied to monitor haloperidol degradation under various stress conditions. For powder samples, the maximum degradation observed was 6.20% after 48 h of sunlight exposure. For liquid haloperidol samples, stability was retained only under oxidative stress conditions, with the highest degradation (57.36%) occurring after 48 h of sunlight exposure and the lowest degradation (10.03%) observed under thermal stress at 60 °C over seven days.


Publication metadata

Author(s): Djilali K, Maachi R, Danish M, Lekmine S, Hadjadj M, Ait Mesbah Z, Benslama O, Tahraoui H, Ola MS, Ali A, Zhang J, Amrane A

Publication type: Article

Publication status: Published

Journal: Processes

Year: 2025

Volume: 13

Issue: 1

Online publication date: 17/01/2025

Acceptance date: 14/01/2025

Date deposited: 03/02/2025

ISSN (electronic): 2227-9717

Publisher: MDPI

URL: https://doi.org/10.3390/pr13010260

DOI: 10.3390/pr13010260

Data Access Statement: The original contributions presented in the study are included in the article, further inquiries can be directed to the corresponding authors.


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Funding

Funder referenceFunder name
King Saud University, Riyadh, Saudi Arabia, Researchers Supporting Project Number (RSPD2025R710)

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