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All Journal Eduvest - Journal of Universal Studies Journal of Pharmaceutical and Sciences.
Purba, Gratia Apulina Cindylawsa
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Aerospace Engineering Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Computer Science & IT Health Professions Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience Nursing Public Health Social Sciences

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Determination of The Level of Paracetamol and Tramadol Hcl Mixture in Tablets by Chemometric Method by Fourier Transform Infrared Spectrophotometry Purba, Gratia Apulina Cindylawsa; Muchlisyam, Muchlisyam; Putra, Effendy De Lux
Eduvest - Journal of Universal Studies Vol. 5 No. 1 (2025): Journal Eduvest - Journal of Universal Studies
Publisher : Green Publisher Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.59188/eduvest.v5i1.50283

Abstract

Fixed-dose combinations of paracetamol and tramadol HCl are effective in the treatment of moderate to severe pain. Therefore, the determination of the levels of the mixture of paracetamol and tramadol HCl is very important for the pharmaceutical industry. The purpose of this study was to determine the levels of paracetamol and tramadol HCl mixture using Fourier Transform Infrared combined with partial least square (PLS) chemometric method. This study was conducted by making a calibration model and chemometric validation of each of the five concentrations measured absorbance at specific wave numbers of paracetamol and tramadol HCl. The results of the study on PLS multivariate calibration of paracetamol and tramadol HCl with RMSECV values of 0.06279 and 0.03785, PRESS values of 0.02366 and 0.00860, and R2 values of 0.9995  0.9998, respectively. All validation parameters are within the acceptable range.  This indicates that the method can be used to accurately determine drug levels without separation
Validasi Metode Analisis KCKT untuk Penetapan Kadar Parasetamol dalam Sediaan Tablet Generik dan Bermerek Harfiansyah, M. Deddy; Purba, Gratia Apulina Cindylawsa; Fitria, Fitria; Rambe , Ummi Khairani; Amar , Ageng Azhar
Journal of Pharmaceutical and Sciences JPS Volume 8 Nomor 4 (2025)
Publisher : Fakultas Farmasi Universitas Tjut Nyak Dhien

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.36490/journal-jps.com.v8i4.1107

Abstract

Background: Paracetamol is one of the most widely used analgesic and antipyretic drugs, and quality control of its dosage forms is crucial to ensure therapeutic effectiveness. Objective: This study aimed to validate a simple, rapid, and reliable High-Performance Liquid Chromatography (HPLC) method for the determination of paracetamol content in generic and branded tablet formulations. Methods: The chromatographic analysis was performed on a C18 column using a mobile phase of distilled water and methanol (3:1, v/v) with a flow rate of 1.0 mL.min–1, injection volume of 20 µL, and detection wavelength at 243 nm. Validation parameters including system suitability, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ) were evaluated according to pharmacopeial guidelines. Results: The method demonstrated excellent linearity over the range of 8–12 µg.mL–1 (r = 0.9998), with LOD and LOQ values of 0.13 µg.mL–1 and 0.40 µg.mL–1, respectively. Accuracy values were 99.00% for generic and 98.86% for branded tablets, while precision showed %RSD of 0.53% and 0.68%. The paracetamol content was 101.47% and 100.20% for generic and branded formulations, respectively, meeting pharmacopeial standards (90–110%). Conclusion: The validated HPLC method proved to be accurate, precise, and sensitive for the quantitative determination of paracetamol in tablet dosage forms. This method is suitable for routine quality control and can be extended for stability or pharmacokinetic studies.
Co-Authors Amar , Ageng Azhar Effendy De Lux Putra, Effendy De Lux Fitria Fitria Harfiansyah, M. Deddy Muchlisyam, Muchlisyam Rambe , Ummi Khairani