Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets

Monica Mame Soma Nyansa; Patrick Doe Fiawoyife; Nana Ama Mireku-Gyimah; John Nii Adotey Addotey

doi:doi:10.11648/j.ijbse.20170504.12

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Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets

Monica Mame Soma Nyansa, Patrick Doe Fiawoyife, Nana Ama Mireku-Gyimah, John Nii Adotey Addotey

Published in International Journal of Biomedical Science and Engineering (Volume 5, Issue 4)

Received: 17 October 2017 Accepted: 31 October 2017 Published: 29 November 2017

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Abstract

An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C₁₈ 250 mm × 4.6 mm, 5-μm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 – 2112.50 ppm for paracetamol and 37.5 – 243.8 ppm for tramadol hydrochloride. The correlation coefficient (r²) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.

Published in	International Journal of Biomedical Science and Engineering (Volume 5, Issue 4)
DOI	10.11648/j.ijbse.20170504.12
Page(s)	41-47
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

RP-HPLC, Paracetamol, Tramadol Hydrochloride, Stability, ICH

References

[1]	P. Hamrapurkar, P. Patil, M. Desai, M. Phale, S. Pawar, “Stress degradation studies and development of a validated stability-indicating-assay-method for determination of diacerein in presence of degradation products,” Pharm Methods, vol. 2 (1), pp. 30-35, Jan 2011.
[2]	ICH Harmonised Tripartite Guideline (2003). Stability Testing of New Drug Substances and Products (Q1AR2).
[3]	U. S. Food and Drug Administration (2017). Combination Products.
[4]	S. Bangalore, G. Kamalakkannan, S. Parkar and F. H. Messerli, “Fixed-Dose combinations improve medication compliance: A Meta-Analysis,” Am J Med, vol. 120 (8), pp. 713-719, August 2007.
[5]	British Pharmacopeia Commission, The British Pharmacopoeia 2013. London: The Stationery Office.
[6]	S. Dhillon, “Tramadol/Paracetamol Fixed-Dose Combination; A review of its use in the management of moderate to severe pain,” Clin Drug Investig, vol. 30 (10), pp. 711-738, 2010.
[7]	S. S. Reuben, “Perioperative use of COX-2 agents,” in Current Therapy in Pain, 1st edn. H. Smith, Eds. Philadelphia: Saunders Elsevier, 2009, pp. 60-62.
[8]	F. Ghorbani-Bidkorbeh, S. Shakrokhian, A. Mohammadi, R. Dinavard, “Simultaneous voltammetric determination of tramadol and acetaminophen using carbon nanoparticles modified glassy electrode,” Electrochimica Acta, vol. 55 (8), pp. 2752-2759, March 2010.
[9]	D. Ravisankar, V. Sridevi, P. G. Kumari, “Development and validation of HPLC method for the simultaneous quantification of acetaminophen and tramadol in combined pharmaceutical dosage forms with UV detection,” International Journal of Applied Biology and Pharmaceutical Technology, vol. 6 (2), pp. 174-181, April 2015.
[10]	M. V. V. N. M. Krishna, S. V. Rao, N. V. S. Venugopal, B. P. V. Mantena, “Simultaneous determination of acetaminophen and tramadol impurities in combination product of acetaminophen and tramadol tablets by UPLC with trifunctional octadecyl column,” TACL, vol. 5, pp. 306-318, 2015.
[11]	R. M. Kamble, S. Singh, “Stability-indicating RP-HPLC method for analysis of paracetamol and tramadol in a pharmaceutical dosage form,” E-Journal of Chemistry, vol. 9 (3), 1347-1356, 2012.
[12]	K. Karunakaran, G. Navaneethan, K. P. Elango, “Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of paracetamol, tramadol HCl and domperidone in a combined dosage form,” Trop J Pharm Res, vol. 11 (1), pp. 99-106, March 2012.
[13]	ICH Harmonised Tripartite Guideline (1996). Validation of Analytical Procedures: Text and Methodology Q2 (R1).
[14]	A. Bose, ‘HPLC calibration process parameters in terms of system suitability test,” Austin chromatogr, vol. 1 (2), pp. 4, 2014.

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APA Style

Monica Mame Soma Nyansa, Patrick Doe Fiawoyife, Nana Ama Mireku-Gyimah, John Nii Adotey Addotey. (2017). Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. International Journal of Biomedical Science and Engineering, 5(4), 41-47. https://doi.org/10.11648/j.ijbse.20170504.12

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ACS Style

Monica Mame Soma Nyansa; Patrick Doe Fiawoyife; Nana Ama Mireku-Gyimah; John Nii Adotey Addotey. Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. Int. J. Biomed. Sci. Eng. 2017, 5(4), 41-47. doi: 10.11648/j.ijbse.20170504.12

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AMA Style

Monica Mame Soma Nyansa, Patrick Doe Fiawoyife, Nana Ama Mireku-Gyimah, John Nii Adotey Addotey. Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. Int J Biomed Sci Eng. 2017;5(4):41-47. doi: 10.11648/j.ijbse.20170504.12

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@article{10.11648/j.ijbse.20170504.12,
  author = {Monica Mame Soma Nyansa and Patrick Doe Fiawoyife and Nana Ama Mireku-Gyimah and John Nii Adotey Addotey},
  title = {Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets},
  journal = {International Journal of Biomedical Science and Engineering},
  volume = {5},
  number = {4},
  pages = {41-47},
  doi = {10.11648/j.ijbse.20170504.12},
  url = {https://doi.org/10.11648/j.ijbse.20170504.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijbse.20170504.12},
  abstract = {An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C18 250 mm × 4.6 mm, 5-μm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 – 2112.50 ppm for paracetamol and 37.5 – 243.8 ppm for tramadol hydrochloride. The correlation coefficient (r2) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.},
 year = {2017}
}

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TY  - JOUR
T1  - Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets
AU  - Monica Mame Soma Nyansa
AU  - Patrick Doe Fiawoyife
AU  - Nana Ama Mireku-Gyimah
AU  - John Nii Adotey Addotey
Y1  - 2017/11/29
PY  - 2017
N1  - https://doi.org/10.11648/j.ijbse.20170504.12
DO  - 10.11648/j.ijbse.20170504.12
T2  - International Journal of Biomedical Science and Engineering
JF  - International Journal of Biomedical Science and Engineering
JO  - International Journal of Biomedical Science and Engineering
SP  - 41
EP  - 47
PB  - Science Publishing Group
SN  - 2376-7235
UR  - https://doi.org/10.11648/j.ijbse.20170504.12
AB  - An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C18 250 mm × 4.6 mm, 5-μm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 – 2112.50 ppm for paracetamol and 37.5 – 243.8 ppm for tramadol hydrochloride. The correlation coefficient (r2) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.
VL  - 5
IS  - 4
ER  -

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Author Information

Monica Mame Soma Nyansa

Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
Patrick Doe Fiawoyife

Manufacturing Division, Ernest Chemists Limited, Tema, Ghana
Nana Ama Mireku-Gyimah

Department of Pharmacognosy, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
John Nii Adotey Addotey

Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

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APA Style

Monica Mame Soma Nyansa, Patrick Doe Fiawoyife, Nana Ama Mireku-Gyimah, John Nii Adotey Addotey. (2017). Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. International Journal of Biomedical Science and Engineering, 5(4), 41-47. https://doi.org/10.11648/j.ijbse.20170504.12

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ACS Style

Monica Mame Soma Nyansa; Patrick Doe Fiawoyife; Nana Ama Mireku-Gyimah; John Nii Adotey Addotey. Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. Int. J. Biomed. Sci. Eng. 2017, 5(4), 41-47. doi: 10.11648/j.ijbse.20170504.12

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AMA Style

Monica Mame Soma Nyansa, Patrick Doe Fiawoyife, Nana Ama Mireku-Gyimah, John Nii Adotey Addotey. Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets. Int J Biomed Sci Eng. 2017;5(4):41-47. doi: 10.11648/j.ijbse.20170504.12

Copy | Download

@article{10.11648/j.ijbse.20170504.12,
  author = {Monica Mame Soma Nyansa and Patrick Doe Fiawoyife and Nana Ama Mireku-Gyimah and John Nii Adotey Addotey},
  title = {Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets},
  journal = {International Journal of Biomedical Science and Engineering},
  volume = {5},
  number = {4},
  pages = {41-47},
  doi = {10.11648/j.ijbse.20170504.12},
  url = {https://doi.org/10.11648/j.ijbse.20170504.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijbse.20170504.12},
  abstract = {An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C18 250 mm × 4.6 mm, 5-μm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 – 2112.50 ppm for paracetamol and 37.5 – 243.8 ppm for tramadol hydrochloride. The correlation coefficient (r2) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.},
 year = {2017}
}

Copy | Download

TY  - JOUR
T1  - Stability-Indicating HPLC Method for the Simultaneous Determination of Paracetamol and Tramadol Hydrochloride in Fixed-Dose Combination Tablets
AU  - Monica Mame Soma Nyansa
AU  - Patrick Doe Fiawoyife
AU  - Nana Ama Mireku-Gyimah
AU  - John Nii Adotey Addotey
Y1  - 2017/11/29
PY  - 2017
N1  - https://doi.org/10.11648/j.ijbse.20170504.12
DO  - 10.11648/j.ijbse.20170504.12
T2  - International Journal of Biomedical Science and Engineering
JF  - International Journal of Biomedical Science and Engineering
JO  - International Journal of Biomedical Science and Engineering
SP  - 41
EP  - 47
PB  - Science Publishing Group
SN  - 2376-7235
UR  - https://doi.org/10.11648/j.ijbse.20170504.12
AB  - An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C18 250 mm × 4.6 mm, 5-μm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 – 2112.50 ppm for paracetamol and 37.5 – 243.8 ppm for tramadol hydrochloride. The correlation coefficient (r2) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.
VL  - 5
IS  - 4
ER  -

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