Validation of an HPLC Analytical Method for the Determination of Paracetamol in Generic and Branded Tablet Dosage Forms
Article Sidebar
Main Article Content
Page: 3032-3038
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.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
References
Freo U. Paracetamol for Multimodal Analgesia. Pain Management. 2022;12(6):737–50. DOI: https://doi.org/10.2217/pmt-2021-0116
Freo U, Ruocco C, Valerio A, Scagnol I, Nisoli E. Paracetamol: A Review of Guideline Recommendations. Journal of Clinical Medicine. 2021;10(15):3420. DOI: https://doi.org/10.3390/jcm10153420
Mallet C, Desmeules J, Pegahi R, Eschalier A. An Updated Review on the Metabolite (AM404)-Mediated Central Mechanism of Action of Paracetamol (Acetaminophen): Experimental Evidence and Potential Clinical Impact. Journal of Pain Research. 2023;16:1081–94. DOI: https://doi.org/10.2147/JPR.S393809
Alotaiq N, Dermawan D. Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry. Pharmaceutics. 2024;16(11):1414. DOI: https://doi.org/10.3390/pharmaceutics16111414
Fernandes EAF, Oudtshoorn J van, Tam A, González LCA, Aurela EG, Potthast H, et al. The Bioequivalence Study Design Recommendations for Immediate-Release Solid Oral Dosage Forms in the International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities. Journal of Pharmacy & Pharmaceutical Sciences. 2024;27:12398. DOI: https://doi.org/10.3389/jpps.2024.12398
Sreedevi A, Ligade VS, Dewan S. Comprehensive Bibliographic Study of the Framework of Complex Generic Drugs. Journal of Taibah University Medical Sciences. 2025;20(2):169–77. DOI: https://doi.org/10.1016/j.jtumed.2025.02.013
Dai R, Watal J. Product Patents and Access to Innovative Medicines. Social Science & Medicine. 2021;291:114479. DOI: https://doi.org/10.1016/j.socscimed.2021.114479
Mostafa S, Mohammad MA, Ebrahim J. Policies and Practices Catalyzing the Use of Generic Medicines: A Systematic Search and Review. Ethiopian Journal of Health Sciences. 2021;31(1):167–78. DOI: https://doi.org/10.4314/ejhs.v31i1.24
Akhtar MS, Orayj K. Evaluation of the Public’s Knowledge, Attitude, and Experiences Towards the Generic Medications in Building Healthcare Policy. PLOS One. 2024; 19(11):e0311627. DOI: https://doi.org/10.1371/journal.pone.0311627
Qu J, Zuo W, Took RL, Schafermeyer KW, Lukas S, Wang S, et al. A Nationwide Survey Exploring Physicians’ and Pharmacists’ Knowledge, Awareness and Perceptions Regarding Generic Medicines in China. BMC Health Services Research. 2022;22:1069. DOI: https://doi.org/10.1186/s12913-022-08438-9
Ntais C, Talias MA, Fanourgiakis J, Kontodimopoulos N. Managing Pharmaceutical Costs in Health Systems: A Review of Affordability, Accessibility and Sustainability Strategies. Journal of Market Access & Health Policy. 2024;12(4):403–14. DOI: https://doi.org/10.3390/jmahp12040031
Ozawa S, Chen HH, Lee YA, Higgins CR, Yemeke TT. Characterizing Medicine Quality by Active Pharmaceutical Ingredient Levels: A Systematic Review and Meta-Analysis across Low- And Middle-Income Countries. American Journal of Tropical Medicine and Hygiene. 2022;106(6):1778–90. DOI: https://doi.org/10.4269/ajtmh.21-1123
Zhu Y, Qin J, Wu W, Cai L. Development and Validation of a Novel High-Performance Liquid Chromatography (HPLC) Method for the Detection of Related Substances of Pralsetinib, a New Anti-Lung Cancer Drug. Frontiers in Chemistry. 2024;12:1450692. DOI: https://doi.org/10.3389/fchem.2024.1450692
Ozgen G, Arda Ozturk NZ, Turan G, Turk M, Gokce EH, Ozer O, et al. Validation of a Simple HPLC/UV Method for Assay and In Vitro Release of Glycosaminoglycan from Pharmaceutical Formulations. ACS Omega. 2024;9(50):49023–31. DOI: https://doi.org/10.1021/acsomega.4c02161
Ulfa DM, Riski N, Irwandi D. Assay of Paracetamol Syrup in Different Storage Temperatures by High Performance Liquid Chromatography. Sanitas: Jurnal Teknologi dan Seni Kesehatan. 2019;10(1):72–80. DOI: https://doi.org/10.36525/sanitas.2019.7
Petrides AK, Dahlin JL, Melanson SEF. Method Validation. In: Clarke W, Marzinke MA, editors. Contemporary Practice in Clinical Chemistry. Amsterdam: Academic Press; 2020. p. 57-72. DOI: https://doi.org/10.1016/B978-0-12-815499-1.00004-1
Jahan MS, Islam MJ, Begum R, Kayesh R, Rahman A. A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method. Analytical Chemistry Insights. 2014;9:75–81. DOI: https://doi.org/10.4137/ACI.S18651
Tanam AA, Khan MF, Rashid RB, Sultan MZ, Rashid MA. Validation and Optimization of a Simple RP-HPLC Method for the Determination of Paracetamol in Human Serum and Its Application in a Pharmacokinetic Study with Healthy Bangladeshi Male Volunteers. Dhaka University Journal of Pharmaceutical Sciences. 2014;13(2):125–31. DOI: https://doi.org/10.3329/dujps.v13i2.21889
Encarnação T, Aguiar A, Palito C, Pais AACC, Campos MG, Sobral AJFN, et al. Development and Validation of an RP-HPLC Method for the Simultaneous Analysis of Paracetamol, Ibuprofen, Olanzapine, and Simvastatin during Microalgae Bioremediation. MethodsX. 2020;7:101083. DOI: https://doi.org/10.1016/j.mex.2020.101083
Goudar N, Tejas B, Sathyanarayana MB, Pai A, Pai V. Quantitative Determination and Validation of Etoricoxib and Paracetamol Combined Tablet Dosage Form by Reverse Phase-HPLC. Rasayan Journal of Chemistry. 2022;15(3):1702–8. DOI: https://doi.org/10.31788/RJC.2022.1537027
United States Pharmacopeial Convention. The United States Pharmacopeia 38 and the National Formulary 33. Washington (DC): USP Convention; 2015.