ABSTRACT:
A new gas chromatographic method has been developed for the simultaneous determination of ibuprofen and paracetamol in bulk and pharmaceutical dosage form, using a TRB-5 column (30m in length, 0.25mm-ID and 0.25?m-DF) and nitrogen as a carrier gas at a flow rate of 1ml.min-1. The oven temperature was programmed at 180°C for 0.5min, with a rise of 15°C up to 250°C. The injector and detector temperature was 300°C. Detection was carried out using Flame Ionization Detector (FID). Methyl paraben was used as an internal standard. The retention times of ibuprofen and paracetamol were (3.681 and 4.089) min respectively. The validation of the method including linearity, range, accuracy, precision, system suitability and robustness was carried out utilizing ICH guidelines. Calibration curves were linear over the range (0.25-1.75)mg/mL for both ibuprofen and paracetamol. The percentage of accuracy for two drugs was found within the acceptance limit of (98–102)%. The precision study results of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) = 2.0%. The proposed method can be easily adopted for the routine analysis of ibuprofen and paracetamol in bulk and pharmaceutical dosage form.
Cite this article:
Celine Zambakjian, Amir Alhaj Sakur. A New Validated Gas Chromatographic Method for the Simultaneous Determination of Ibuprofen and Paracetamol in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2020; 13(11):5103-5107. doi: 10.5958/0974-360X.2020.00893.8
Cite(Electronic):
Celine Zambakjian, Amir Alhaj Sakur. A New Validated Gas Chromatographic Method for the Simultaneous Determination of Ibuprofen and Paracetamol in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2020; 13(11):5103-5107. doi: 10.5958/0974-360X.2020.00893.8 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-11-8
REFERENCES:
1. Sweetman SC. Martindale: The Complete Drug Reference 36th edition. Royal Pharmaceutical Society Publishing, United Kingdom. 2009.
2. Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. American Dental Association. 2002; 133: 861–871.
3. Desmeules J et al. Clinical pharmacology and rationale of analgesic combinations. The European Journal of Anaesthesiology. 2003; 28: 7–11.
4. Merry AF et al. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. British Journal of Anaesthesia. 2010; 104(1): 80-88.
5. Moffat AC et al. Clarke’s Analysis of Drugs and Poisons 4th edition. Royal Pharmaceutical Society Publishing, United Kingdom. 2011.
6. The United States Pharmacopeia: USP 30-the National Formulary: NF 25: by authority of the United States Pharmacopeial Convention, Inc., meeting at Washington, D.C., 2007.
7. The British Pharmacopoeia, Stationery Office, United Kingdom (2009).
8. Cretu G et al. Separation of the enantiomers of ibuprofen by a Gas Chromatographic–Mass Spectrometric method. Acta Chromatographica. 2005; 15: 315-321.
9. Caviglioli G et al. Identification of degradation products of ibuprofen arising from oxidative and thermal treatments. Journal of Pharmaceutical and Biomedical Analysis. 2002; 30: 499-509.
10. Pattanaik S et al. Assay method development and validation of ibuprofen tablets by HPLC. Der Pharmacia Sinica. 2013; 4(4): 91-96.
11. Radi M et al. Optimization and validation of a method for determination of ibuprofen by HPLC in different pharmaceutical forms: Tablet, syrup, gel and suppository. Journal of Chemical and Pharmaceutical Research. 2014; 6(8): 301-304.
12. Matkovic SR et al. Quantitative analysis of ibuprofen in pharmaceutical formulations through FTIR spectroscopy. 2005; 35: 189-195.
13. Sunaric S. Determination of ibuprofen in combined dosage forms and cream by direct UV spectrophotometry after solid-phase extraction. Acta Poloniae Pharmaceutica-Drug Research. 2013; 70(3): 403-411.
14. Zayed MA, EL-Gizouli AMM. Spectrophotometric study and determination of ibuprofen and lornoxicam drugs via their reaction with copper (II) reagent and their biological activities. Journal of Pharmaceutical and Applied Chemistry. 2017; 3(1): 75-82.
15. Mitić SS. et al. Quantitative analysis of ibuprofen in pharmaceuticals and human control serum using kinetic spectrophotometry. Journal of the Serbian Chemical Society. 2008; 73(8–9): 879–890.
16. Damiani PC et al. Spectrofluorometric determination of ibuprofen in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis. 2001; 25: 679–683.
17. Bahram M et al. Simultaneous colorimetric determination of morphine and ibuprofen based on the aggregation of gold nanoparticles using partial least square. Journal of Pharmaceutical Analysis. 2017; 7: 411–416.
18. Dechtlaruk WA et al. Gas-Chromatographic method for acetaminophen (N-acetyl-p-aminophenol) based on sequential alkylation. Clinical Chemistry. 1976; 22(6): 879-883.
19. Speed DJ et al. Analysis of paracetamol using solid-phase extraction, deuterated internal standards, and Gas Chromatography-Mass Spectrometry. Journal of Analytical Toxicology. 2001; 25: 198-202.
20. Habekost A. The analysis of paracetamol – A comparison between electrochemistry, electrochemiluminescence and GC-MSD. World Journal of Chemical Education. 2017; 5(2): 37-45.
21. Belal T et al. Determination of paracetamol and tramadol hydrochloride in pharmaceutical mixture Using HPLC and GC–MS. Journal of Chromatographic Science. 2009; 47: 849-854.
22. Badgujar MA. Simultaneous determination of paracetamol, chlorzoxazone and diclofenac sodium in tablet dosage form by High Performance Liquid Chromatography. E-Journal of Chemistry. 2011; 8(3): 1206-1211.
23. Gopinath R et al. A RP-HPLC method for simultaneous estimation of paracetamol and aceclofenac in tablets. Indian Journal of Pharmaceutical Sciences. 2007; 69(1): 137-140.
24. Lalitha KV. RP-HPLC method development and validation for the simultaneous estimation of paracetamol and flupiritine maleate in pharmaceutical dosage. Journal of Scientific and Innovative Research. 2013; 2(3): 634-641.
25. Dixit RB, Patel JA: Spectrophotometric determination of paracetamol drug using 8-hydroxyquinoline. International Journal of Pharmaceutical Sciences and Research. 2014; 5(6): 2393-2397.
26. Saeed AM. Spectrophotometric determination of paracetamol in some manufactured tablets in Iraqi markets. International Journal of Pharmaceutical Sciences Review and Research. 2017; 42(2): 53-57.
27. Ni Y et al. Differential pulse stripping voltammetric determination of paracetamol and phenobarbital in pharmaceuticals assisted by chemometrics. Analytical Letters. 2004; 37(15): 3219–3235.
28. Bosch ME et al. Determination of paracetamol: Historical evolution. Journal of Pharmaceutical and Biomedical Analysis. 2006; 42: 291–321.
29. Battu PR, Reddy MS. RP-HPLC method for simultaneous estimation of paracetamol and ibuprofen in tablets. Asian Journal of Research in Chemistry. 2009; 2(1): 70–72.
30. Jahan MS et al. 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.
31. Borahan T et al. A rapid and sensitive reversed phase HPLC method for simultaneous determination of ibuprofen and paracetamol in drug samples and their behaviors in simulated gastric conditions. Journal of Separation Science. 2018; 1–6.
32. Alsaad AAA et al. The simultaneous determination of ibuprofen and paracetamol in pharmaceutical formulations by High Performance Liquid Chromatography with Ultraviolet Detection. Asian Journal of Pharmaceutics. 2019; 13(2): 141-152.
33. Gondalia R et al. Development and validation of spectrophotometric methods for simultaneous estimation of ibuprofen and paracetamol in soft gelatin capsule by smultaneous equation method. International Journal of ChemTech Research. 2010; 2(4): 1881-1885.
34. Issa YM et al. Simultaneous determination of ibuprofen and paracetamol using derivatives of the ratio spectra method. Arabian Journal of Chemistry. 2011; 4: 259–263.
35. Gaikwad R et al. Development and validation of analytical method for simultaneous estimation of paracetamol and ibuprofen using UV-Visible Spectroscopy. International Journal Of Pharmacy & Pharmaceutical Research. 2017; 11(1): 389-396.
36. Giri TK, Tripathi DK. Simultaneous equation method for simultaneous estimation of paracetamol and ibuprofen in combined dosage form. International Journal of Pharmaceutical & Biological Archives. 2010; 1(2): 189 – 192.
37. Hassan WS. Determination of ibuprofen and paracetamol in binary mixture using chemometric-assisted spectrophotometric methods. American Journal of Applied Sciences. 2008; 5(8): 1005-1012.
38. Joshi RS et al. Development and validation of UV spectrophotometric methods for simultaneous estimation of paracetamol and ibuprofen in pure and tablet dosage form. Der Pharmacia Sinica. 2011, 2(3): 164-171.
39. Mallah MA et al. Simultaneous quantification of ibuprofen and paracetamol in tablet formulations using Transmission Fourier Transform Infrared Spectroscopy. American Journal of Analytical Chemistry. 2012; 3: 503-511.
40. Luna AS, Pinho JSA. Determination of paracetamol and ibuprofen in tablets and urine using Spectrofluorimetric determination coupled with chemometric tools. Austin Journal of Analytical and Pharmaceutical Chemistry. 2014; 1(1): 1-7.
41. International Conference on Harmonisation (ICH) Harmonised Tripar-tite Guideline: Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005.