METHOD DEVELOPMENT AND VALIDATION OF RAPID ISOCRATIC RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL, CAFFEINE, AND PROPYPHENAZONE IN PHARMACEUTICAL FORMULATION
DOI:
https://doi.org/10.22159/ajpcr.2024.v17i4.49544Keywords:
Paracetamol, caffeine, Propyphenazone, RP- HPLC, ValidationAbstract
Objective: The objective is to develop a novel, rapid, simple, precise, accurate, and reproducible RP-HPLC method for simultaneous estimation of paracetamol, caffeine, and propyphenazone in bulk and a pharmaceutical dosage form.
Method: Optimized chromatographic conditions were used for isocratic elution with Shimadzu C18 (4.6×250 mm, 5 μm), methanol, and 20mM phosphate buffer (60:40, v/v, pH 2.5) as mobile phase, flow rate 1.2 mL/min, and UV detector at λ max 272 nm. The method was validated for specificity, precision, linearity, accuracy, robustness, and solution stability as per the International Council for Harmonization (ICH) guidelines.
Result: It was discovered that the retention time for paracetamol, caffeine, and propyphenazone was found to be 2.6 min, 3.0 min, and 7.5 min. The method proved to be rapid, simple, linear (R2>0.999), precise {relative standard deviation (RSD<2.0%)}, accurate (recovery 98–102%), sensitive, and robust.
Conclusion: The proposed novel isocratic RP-HPLC method was found to be rapid (short run time of 10 min), highly selective, accurate, and sensitive. The method has been successfully applied to the simultaneous analysis of paracetamol, caffeine, and propyphenazone in a pharmaceutical formulation.
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Freo U, Ruocco C, Valerio A, Scagnol I, Nisoli E. Paracetamol: A review of guideline recommendations. J Clin Med. 2021 Jul 31;10(15):3420. doi: 10.3390%2Fjcm10153420
Ayoub SS. Paracetamol (acetaminophen): A familiar drug with an unexplained mechanism of action. Temperature (Austin). 2021;8(4):351-371. doi: 10.1080/23328940.2021.1886392
Forrest JA, Clements JA, Prescott LF. Clinical pharmacokinetics of paracetamol. Clin Pharmacokinet. 1982 Mar-Apr;7(2):93-107. doi: 10.2165/00003088-198207020-00001
Gemta AB. Properties and analysis of caffeine and chlorogenic acids in coffee beans. In: Coffee Consumption and Health. New York: Nova Publisher; 2012. Available from: https://www.researchgate.net/ publication/268220418_book_chapter_properties_and_analysis_of_ caffeine_and_chlorogenic_acids_in_coffee_beans [Last accessed on 2023 Jan 25].
Heishman SJ, Henningfield JE. Stimulus functions of caffeine in humans: Relation to dependence potential. Neurosci Biobehav Rev. 1992;16(3):273-287. doi: 10.1016/S0149-7634(05)80202-7
Radwan MF, Dalby KN, Kaoud TS. Propyphenazone-based analogues as prodrugs and selective cyclooxygenase-2 inhibitors. ACS Med Chem Lett. 2014 Jun 23;5(9):983-8. doi: 10.1021%2Fml500156v
Delvadiya K, Kabra P, Kimbahune R, Patel N, Nargund L. High-performance liquid chromatographic determination of paracetamol, propyphenazone, and caffeine in pharmaceutical formulations. Indian J Pharm Educ Res. 2013;47:65-72.
Mamolo MG, Vio L, Maurich V. Simultaneous quantitation of paracetamol, caffeine and propyphenazone by high-pressure liquid chromatography. J Pharm Biomed Anal. 1985;3(2):157-64. doi: 10.1016/0731-7085(85)80019-4
Acheampong A, Gyasi WO, Darko G, Apau J, Addai-Arhin S. Validated Rp-Hplc method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation. Springerplus. 2016;5:625. doi: 10.1186/S40064-016- 2241-2
ICH Guidelines. Available from: https://database.ich.org/sites/default/ files/Q2%28R1%29%20Guideline.pdf [Last accessed on 2023 Apr 22].
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