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Development and validation of analytical method for ethanol content in medicinal cough syrup

Sultan, Siti Fatimah and Susanti, Hari and Mohamed, Farahidah and Salamah, Nina and Farida, Verda (2025) Development and validation of analytical method for ethanol content in medicinal cough syrup. Journal of Halal Science and Research, 6 (1). pp. 92-101. ISSN 2715-6214 E-ISSN 2964-4909

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Abstract

Cough syrup is a pharmaceutical preparation often containing ethanol as a solvent. However, the presence of ethanol in the drug can cause safety issues. This study aims to develop and validate a colorimetric method for determining ethanol in cough syrup. Cough syrup samples from different brands were analyzed using the method. The Visible spectrophotometric method uses the oxidation reaction of ethanol with potassium dichromate in an acidic condition. Method validation was conducted, including linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The results showed this method had good linearity (r > 0.99) with a concentration range of 0.48 – 5.76 % (b/v). UV-Vis spectrophotometric method showed good precision and accuracy with SD = 0.0014, RSD = 0.4046 %, and % recovery = 99.99 %, while LOD = 0.1074 % and LOQ = 0.3253 %. This study concludes that the colorimetric method can be used as a valid and complementary method for analyzing ethanol content in cough syrup, providing important information for producers and consumers regarding product safety.

Item Type: Article (Journal)
Uncontrolled Keywords: Analytical method validation, Cough syrup, Ethanol, Spectrophotometry
Subjects: R Medicine > RM Therapeutics. Pharmacology
R Medicine > RS Pharmacy and materia medica
R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology
R Medicine > RS Pharmacy and materia medica > RS403 Materia Medica-Pharmaceutical Chemistry
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Pharmacy
Kulliyyah of Pharmacy > Department of Pharmaceutical Technology
Depositing User: Prof Dr. Farahidah Mohamed
Date Deposited: 31 Dec 2025 10:52
Last Modified: 31 Dec 2025 10:52
Queue Number: 2025-12-Q1422
URI: http://irep.iium.edu.my/id/eprint/126577

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