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Development and Validation of a Simple and Sensitive Reverse-Phase High Performance Liquid Chromatographic Method for the Determination of Ibuprofen in Pharmaceutical Suspensions


  • Kenan G. Elias Department of Pharmaceutical Chemistry and Drug Quality Control, Faculty of Pharmacy, Al-Baath University, Homs, Syria.
  • Yumen Hilal Department of Pharmaceutical Analytical and Food Chemistry, Faculty of Pharmacy, Al-Baath University, Homs, Syria.



Developed, Ibuprofen, Method validation, RP-HPLC, Suspension


The aim of this work was to develop and validate a rapid and low cost method for estimation of ibuprofen in pharmaceutical suspensions using Reverse-Phase High Performance Liquid Chromatography. The proposed method was conducted and validated according to International Conference on Harmonization (ICH) requirements. The chromatographic parameters were as follows: column of octyldecylsilyl C18 with dimensions (150 × 4.6) mm, mobile phase composed of acetonitrile with phosphoric acid with a ratio of 50 to 50 each using isocratic mode, flow rate of 1.5 mL/min and injection volume of 5 μL. The detection was carried out using UV detector at 220 nm. The method was validated and showed short retention time for ibuprofen peak at 7.651 min, with linearity in the studied range of 0.4 - 1.6 mg/mL (R2 = 0.9999) and with great accuracy ]percent recovery was (100.48%), percent relative error(-1.511-1.465)%[ and repeatability (RSD% = 0.112 for Retention time). The detection and quantitation limits were determined to be 0.036 and 0.110 mg/mL, respectively. This method was applied successfully to determine the content of ibuprofen in three commercial pharmaceutical products. Looking at the short time of analysis and the low limit detection, we recommend this method for routine assays in the quality control laboratories and as a good method for stability studies of ibuprofen.


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Zappaterra F, Rodriguez M.E.M, Summa D, Semeraro B, Costa S, Tamburini E. Biocatalytic Approach for Direct Esterification of Ibuprofen with Sorbitol in Biphasic Media. Int J Mol Sci. 2021; 22(6): 1-18.

United States Pharmacopeial Convention. U.S. Pharmacopeia National Formulary USP 41 NF36 second supplement, Washington. Official Monographs/Ibuprofen. 2018: 2109-2114.

Mazaleuskaya LL, Theken KN, Gong L, Thorn CF, FitzGerald GA, Altman RB, et al. PharmGKB summary: ibuprofen pathways. Pharmacogenet Genomics. 2015; 25(2): 96–106.

Feng X, Wang X. Comparison of the Efficacy and Safety of Non-Steroidal Anti-Inflammatory Drugs for Patients with Primary Dysmenorrhea: A Network Meta-Analysis. Mol Pain. 2018; 14: 1-43.

Kaci D M. Ibuprofen,”, Jan. 28, 2021.

Buckingham R. Martindale: The Complete Drug Reference. 40th ed. London: Pharmaceutical Press, 2020. 4912 P.

Gondalia R, Mashru R, Savaliya P. Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Ibuprofen and Paracetamol in Soft gelatin capsule by Simultaneous Equation Method. Int J Chemtech Res. 2010; 2(4): 1881–1885.

Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, et al. Cyclooxygenase Inhibitors and the Antiplatelet Effects of Aspirin. N Engl J Med. 2001; 345(25): 1809–1817.

Yahya NM, AL-Dabbagh SG. Kinetic Study of the Hydrolysis of synthesized Ibuprofen Ester and its Biological Activity. Baghdad Sci J. 2013; 10(3): 1062–1070.

Stationery Office (Londyn) and British Pharmacopoeia commission. The British Pharmacopoeia (BP). London: Stationery Office. 2019; 3: p. I-1286, I-1287, III-752, III-753.

Ponnada VNL. Formulation and Evaluation of Ibuprofen Suspension Using Natural and Synthetic Suspending Agents. World J Pharm Res. 2017; 1: 1509–51.

Sudhir M, Divya C, Lakshmi Prasanti N, Liakhat Ali S, Jyothi N, Fridepaul C. Formulation and Characterization of Oral Suspension Containing Ibuprofen. Asian j pharm technol innov. 2016; 4(21): 23–32.

Rubenick JB, Rubim AM, Santos MR dos, Santos TS, Laporta LV. Quality control and comparative dissolution profile of Ibuprofen oral suspension. Rev Bras Farm. 2014; 95(3): 924–39.

De La Guardia M, Garrigues S. Past, Present and Future of Green Analytical Chemistry. In: Garrigues S, de la Guardia M, editors. 2nd ed. Cambridge: Royal Society of Chemistry; 2020. Chap 1, P. 1–18. Available from:

International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva, Switzerland. 2005;17.

The United States Pharmacopeial Convention USP 39, NF 19. Verification of Compendial Procedures / General Information, <1226>. In 2016; p. 1640–6.

Alsirawan MB, Mohammad M, Alkasmi B, Alhareth K, El-Hammadi M. Development and Validation of a Simple HPLC Method for the Determination of Ibuprofen Sticking onto Punch Faces. Int J Pharm Pharm Sci. 2013; 5(4): 227–31.

Shabir G. Step-by-step analytical methods validation and protocol in the quality system compliance industry. 2004;10: 314–24.

Abualhasan M, Zohud N, Ghazal N .RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine. Int J Anal Chem. 2020; 2020:1-9

Batrawi N, Naseef H, Al-Rimawi F. Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Florfenicol and Flunixin Meglumine Combination in an Injectable Solution. J Anal Methods Chem. 2017; 2017:1–7.

Abdalraheem A, Shantier S, Abureid I, Gadkariem E A. Stability-Indicating High-Performance Liquid Chromatographic Determination of Levamisole Hydrochloride in Bulk and Dosage Forms. J. Chem. 2020; 2020:1-8.

Mohammed ZH. Determination of Nicotine Extracted from Eggplant and Green Pepper by HPLC. Baghdad Sci J. 2019;16(1) :61–7.

Kawano Y, Chen S, Hanawa T. Solubility Enhancement of Ibuprofen by Adsorption onto Spherical Porous Calcium Silicate. Pharmaceutics. 2021;13(6): 767. doi: 10.3390/pharmaceutics13060767. PMID: 34063903; PMCID: PMC8224037.