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International Journal of Medicine and Science of Physical Activity and Sport

International Journal of Medicine and Science of Physical Activity and Sport

REVISTA INTERNACIONAL DE MEDICINA Y CIENCIAS DE LA ACTIVIDAD FÍSICA Y EL DEPORTE

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COLLABORATIVE RP-HPLC METHOD DEVELOPMENT FOR MODAFINIL AND SCOPOLAMINE HYDROBROMIDE IN SUBLINGUAL TABLETS: INVOLVING KEY INDUSTRY PLAYERS

Issue Volume 23, Number 92, 2023 Articles 
Pei Chen
Department of Pharmacy, Naval Medical University, shanghai 200433, China
Li Fan
Department of Pharmacy, Naval Medical University, shanghai 200433, China
Guangzhao Lu
Department of Pharmacy, Naval Medical University, shanghai 200433, China
Ying Lu
Department of Pharmacy, Naval Medical University, shanghai 200433, China

Abstract

Objective: This research aims to develop and validate a collaborative RP-HPLC method, with input from key industry players, for the simultaneous determination of modafinil and scopolamine hydrobromide in compound sublingual tablets. The focus is on ensuring the safety and efficacy of these substances for enhancing the physical and cognitive fitness of athletes and players. Method: Utilizing a C18 chromatographic column (200mm×4.6mm, 5μm), the method employs a mobile phase of acetonitrile-water (25:75) with 0.02mol/L ammonium acetate and 0.02% triethylamine, pH adjusted to 6.0. The flow rate was set at 1 mL/min, detection at 225 nm wavelength, and an injection volume of 20 μL.Results: Scopolamine hydrobromide showed a linear range of 1-50 μg/mL, with a standard curve equation of A=0.2187C+0.0708 (R²=0.9993), and modafinil exhibited a range of 10-500 μg/mL, with A=0.6702C-1.6855 (R²=0.9993). Both substances demonstrated average recoveries of over 99%, within acceptable variance limits, signifying reliable quantification for fitness-related applications. Conclusion: The developed method is sensitive, precise, accurate, and reproducible, conforming to the standards of the Chinese Pharmacopoeia (2020 edition). It is particularly valuable for monitoring the quality of substances used by athletes and players to ensure their safe application in enhancing fitness and performance. The method benefits significantly from the collaboration with industry experts, addressing the specific needs of fitness and sports professionals.

Keywords: scopolamine hydrobromide; compound sublingual tablet; high performance liquid chromatography; content; Sports Pharmacology; Athlete Fitness
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Periodicidad Trimestral/Quartely
Revista multidisciplinar de las Ciencias del Deporte
ISSN: 1577-0354
All journal articles are published in Spanish together with their corresponding translation into English

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