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Simultaneous Spectrophotometric Determination of Dexketoprofen Trometamol and Thiocolchicoside by Using Principal Component Regression Multivariate Calibration Model in Combined Pharmaceutical Formulation

Year 2023, Volume: 3 Issue: 4, 99 - 104, 09.10.2023

Abstract

Objective: The combination of the non-steroidal anti-inflammatory drug dexketoprofen trometamol (DXT) and the centrally acting muscle relaxant thiocolchicoside (TH) is used for symptomatic relief in various conditions, with the aim of alleviating associated symptoms. The study involves the development, validation, and application of the chemometrics-based spectrophotometric method.

Methods: An integral aspect of the investigation is the strategic application of experimental design techniques for calibration and validation mixtures to facilitate the assessment of factor effects within complex matrices. In this study, a factorial design was used to prepare calibration (25 samples) and validation (8 samples) sets comprising mixtures of DXT and TH within their linear ranges (2.5-25 μg/mL for DXT and 2-16 μg/mL for TH).

Results: Spectra of the acquired mixtures and samples were recorded at wavelengths between 220nm and 460 nm at Δλ = 1 nm intervals. Using regression models based on the principal component regression algorithm, the results obtained showed satisfactory performance, with a recovery rate of ≤98.54% for DXT and ≤98.88% for TH.

Conclusion: These models offer the potential for accurate identification and quantification of DXT and TH in pharmaceutical preparations

Ethical Statement

There was no need for ethics committee approval for this study. The research conducted did not involve human subjects, animal experimentation, or sensitive personal data. Therefore, ethical approval was not required in accordance with the established regulations and guidelines governing research ethics.

References

  • 1. Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021;397(10289):2082- 2097. [CrossRef]
  • 2. Woolf CJ. What is this thing called pain? J Clin Invest. 2010;120(11):3742- 3744. [CrossRef]
  • 3. Hanna M, Moon JY. A review of dexketoprofen trometamol in acute pain. Curr Med Res Opin. 2019;35(2):189-202. [CrossRef]
  • 4. Rodríguez MJB, Arbós RMA, Amaro SR. Dexketoprofen trometamol: clinical evidence supporting its role as a painkiller. Expert Rev Neurother. 2008;8(11):1625-1640. [CrossRef]
  • 5. Chaudhari B, Trivedi J. Simultaneous spectrophotometric estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form. Int J Biomed Adv Res. 2012;3(3):179-183.
  • 6. Kuczyńska J, Pawlak A, Nieradko-Iwanicka B. The comparison of dexketoprofen and other painkilling medications (review from 2018 to 2021). Biomed Pharmacother. 2022;149:112819. [CrossRef]
  • 7. El-Ragehy NA, Ellaithy MM, El-Ghobashy MA. Determination of thiocolchicoside in its binary mixtures (thio colch icosi de–gl afeni ne and thioc olchi cosid e–flo ctafe nine) by TLC densitometry. Farmaco. 2003;58(6):463-468. [CrossRef]
  • 8. Mascia MP, Bachis E, Obili N, et al. Thiocolchicoside inhibits the activity of various subtypes of recombinant GABAA receptors expressed in Xenopus laevis oocytes. Eur J Pharmacol. 2007;558(1-3):37-42.
  • 9. Cigerim L, Kaplan V. Evaluation of the analgesic efficacies of dexketoprofen trometamol and dexketoprofen trometamol + thiocolchicoside combinations in the impacted third molar surgery: randomised clinical trial. Med Oral Patol Oral Cir Bucal. 2019;24(1):e114-e122.
  • 10. Manohar Y, Rajesh G, Bindu Pekha P, Kumar A, Ahmed S. Comparison of analgesic effects of thiocolchicoside and ketoprofen, and their combination in animal models. Pharma Innov. 2018;7(10):419-422.
  • 11. Manohar Y, Rajesh G, Bindu Pekha P, Kumar A, Ahmed S. A comparative study of analgesic effect of thiocolchicoside, ketoprofen and their combination in rats, using digital analgesiometer. Pharma Innov. 2018;7(10):376-378.
  • 12. Krunal P, Mehta D. Development and validation of UV spectroscopic and RP-HPLC methods for estimation of dexketoprofen trometamol in tablet dosage form. J Pharm Sci Bio Res. 2010;2(1):65-71.
  • 13. Öztürk AA, Yenilmez E, Yazan Y. Development and validation of high performance liquid chromatography (HPLC) modified method fordexketoprofen trometamol. Eur Int J Sci Tec. 2017;6(5):33-41.
  • 14. Mulla TS, Rao JR, Yadav SS, Bharekar VV, Rajput MP. Development and validation of HPLC method for simultaneous quantitation of paracetamol and dexketoprofen trometamol in bulk drug and formulation. Pharm Glob. 2011;7:1-4.
  • 15. Ankush JP, Datar PA, Kedar TR, Kardile DP, Shete RV. Analytical method development and validation of thiocolchicoside and ibuprofen in tablet dosage form by UV spectrophotometry method. Res J Pharm Technol. 2021;14(2):981-985. [CrossRef]
  • 16. Vanparia D, Shah SA, Marolia BP, Bodiwala KB, Ptadia RK. Spectrophotometric methods for simultaneous estimation of thiocolchicoside and diclofenac sodium in their combined dosage form. Asian J Chem. 2011;4(1):123-127.
  • 17. Albayrak M, Demirkaya Miloğlu F, Şenol O, Polatdemir E. Design, optimization, and validation of chemometrics-assisted spectrophotometric methods for simultaneous determination of etodolac and thiocolchicoside in pharmaceuticals. J Anal Sci Technol. 2019;10(1):1-8.
  • 18. Jadhav SD, Butle SR, Patil SD, Jagtap PK. Validated stability indicating RP-HPLC method for simultaneous determination and in vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arab J Chem. 2015;8(1):118-128. [CrossRef]
  • 19. Chitlange SS, Shinde PS, Pawbake GR, Wankhede SB. Simultaneous estimation of thiocolchicoside and aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Pharm Lett. 2010;2(2):86-93
  • 20. Tank PK, Shah RR, Shukla MH, Nayak PP, Patel AP. Development and validation of first order derivative spectroscopic method for simultaneous estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form. Pharma Science Monitor. 2012;3(4):0976-7908.
  • 21. Bhavsar A, Joshi T, Vikani K, Senta A. Development and validation of UV-Visible spectrophotometric method for simultaneous estimation of ketoprofen and thiocolchicoside in solid oral dosage form. Int Res J Pharm. 2016;7(5):53-58. [CrossRef]
  • 22. Wankhede SB, Zambare SS, Chitlange SS. Estimation of thiocolchicoside and ketoprofen in pharmaceutical dosage form by spectrophotometric methods. J Pharm Res. 2010;3:34-39.
  • 23. Joshi T, Bhavsar A, Senta A. Development and Validation of spectrophotometric Method for Simultaneous Estimation of ketoprofen and thiocolchicoside in combined Solid Oral Dosage Form. Int J Pharm Life Sci. 2016;7(4):4979-4986.
  • 24. Trivedi SA, Joshi DM, Patel SG, Patel AJ. Optimization of mobile phase of high performance liquid chromatography using full factorial design for simultaneous estimation of thiocolchicoside and dexketoprofen trometamol in tablets. Biquarterly Iran J Anal Chem. 2015;2(1):14-21.
  • 25. Dhaneshwar SR, Jagtap VN. Development and validation of RPHPLC- PDA method for simultaneous determination of dexketoprofen and thiocolchicoside in pharmaceutical dosage form. J Pharm Res. 2013;6(6):604-608. [CrossRef]
  • 26. Wankhede SB, Zambare SS, Dixit NR, Chitlange SS. RP-HPLC method for simultaneous estimation of thiocolchicoside and ketoprofen in combined dosage form. Pharm Lett. 2010;2(3):315-320.
  • 27. Wankhede SB, Chitlange SS, Bhole RP, Zambare SS. A simple and sensitive HPTLC method for simultaneous analysis of thiocolchicoside and ketoprofen in combined dose tablet formulation. Anal Chem Lett. 2012;2(5):301-308. [CrossRef] 28. Patil VK, Gawad JB, Mhaske AJ. Simultaneous estimation of thin layer liquid chrom atogr aphy/ densi tomet ry method for thiocolchicoside and dexketoprofen in bulk and in tablet dosage form. J Appl Chem. 2013;2(4):913-921.
  • 29. Demirkaya AK, Demirkaya Miloglu F, Senol O. UV-vis spect ropho tomet ric-a ssist ed chemometric calibration models for simultaneous determination of thiamine and pyridoxine vitamins in powdered infant formula. Maced Pharm Bull. 2021;67(2):33-41.
  • 30. Fares MY, Abdelwahab NS, Hegazy MA, Abdelrahman MM, El-Sayed GM. Comparative chemometric manipulations of UVspectrophotometric data for the efficient resolution and determination of overlapping signals of cyclizine and its impurities in its pharmaceutical preparations. J AOAC Int. 2022;106(1):228-238.
  • 31. Keithley RB, Wightman RM, Heien ML. Multivariate concentration determination using principal component regression with residual analysis. Trends Analyt Chem. 2009;28(9):1127-1136.

Simultaneous Spectrophotometric Determination of Dexketoprofen Trometamol and Thiocolchicoside by Using Principal Component Regression Multivariate Calibration Model in Combined Pharmaceutical Formulation

Year 2023, Volume: 3 Issue: 4, 99 - 104, 09.10.2023

Abstract

Objective: The combination of the non-steroidal anti-inflammatory drug dexketoprofen trometamol
(DXT) and the centrally acting muscle relaxant thiocolchicoside (TH) is used for symptomatic
relief in various conditions, with the aim of alleviating associated symptoms. The study
involves the development, validation, and application of the chemometrics-based spectrophotometric
method.
Methods: An integral aspect of the investigation is the strategic application of experimental
design techniques for calibration and validation mixtures to facilitate the assessment of factor
effects within complex matrices. In this study, a factorial design was used to prepare calibration
(25 samples) and validation (8 samples) sets comprising mixtures of DXT and TH within their linear
ranges (2.5-25 μg/mL for DXT and 2-16 μg/mL for TH).
Results: Spectra of the acquired mixtures and samples were recorded at wavelengths between
220nm and 460 nm at Δλ = 1 nm intervals. Using regression models based on the principal component
regression algorithm, the results obtained showed satisfactory performance, with a
recovery rate of ≤98.54% for DXT and ≤98.88% for TH.
Conclusion: These models offer the potential for accurate identification and quantification of DXT
and TH in pharmaceutical preparations

Ethical Statement

There was no need for ethics committee approval for this study. The research conducted did not involve human subjects, animal experimentation, or sensitive personal data. Therefore, ethical approval was not required in accordance with the established regulations and guidelines governing research ethics.

References

  • 1. Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021;397(10289):2082- 2097. [CrossRef]
  • 2. Woolf CJ. What is this thing called pain? J Clin Invest. 2010;120(11):3742- 3744. [CrossRef]
  • 3. Hanna M, Moon JY. A review of dexketoprofen trometamol in acute pain. Curr Med Res Opin. 2019;35(2):189-202. [CrossRef]
  • 4. Rodríguez MJB, Arbós RMA, Amaro SR. Dexketoprofen trometamol: clinical evidence supporting its role as a painkiller. Expert Rev Neurother. 2008;8(11):1625-1640. [CrossRef]
  • 5. Chaudhari B, Trivedi J. Simultaneous spectrophotometric estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form. Int J Biomed Adv Res. 2012;3(3):179-183.
  • 6. Kuczyńska J, Pawlak A, Nieradko-Iwanicka B. The comparison of dexketoprofen and other painkilling medications (review from 2018 to 2021). Biomed Pharmacother. 2022;149:112819. [CrossRef]
  • 7. El-Ragehy NA, Ellaithy MM, El-Ghobashy MA. Determination of thiocolchicoside in its binary mixtures (thio colch icosi de–gl afeni ne and thioc olchi cosid e–flo ctafe nine) by TLC densitometry. Farmaco. 2003;58(6):463-468. [CrossRef]
  • 8. Mascia MP, Bachis E, Obili N, et al. Thiocolchicoside inhibits the activity of various subtypes of recombinant GABAA receptors expressed in Xenopus laevis oocytes. Eur J Pharmacol. 2007;558(1-3):37-42.
  • 9. Cigerim L, Kaplan V. Evaluation of the analgesic efficacies of dexketoprofen trometamol and dexketoprofen trometamol + thiocolchicoside combinations in the impacted third molar surgery: randomised clinical trial. Med Oral Patol Oral Cir Bucal. 2019;24(1):e114-e122.
  • 10. Manohar Y, Rajesh G, Bindu Pekha P, Kumar A, Ahmed S. Comparison of analgesic effects of thiocolchicoside and ketoprofen, and their combination in animal models. Pharma Innov. 2018;7(10):419-422.
  • 11. Manohar Y, Rajesh G, Bindu Pekha P, Kumar A, Ahmed S. A comparative study of analgesic effect of thiocolchicoside, ketoprofen and their combination in rats, using digital analgesiometer. Pharma Innov. 2018;7(10):376-378.
  • 12. Krunal P, Mehta D. Development and validation of UV spectroscopic and RP-HPLC methods for estimation of dexketoprofen trometamol in tablet dosage form. J Pharm Sci Bio Res. 2010;2(1):65-71.
  • 13. Öztürk AA, Yenilmez E, Yazan Y. Development and validation of high performance liquid chromatography (HPLC) modified method fordexketoprofen trometamol. Eur Int J Sci Tec. 2017;6(5):33-41.
  • 14. Mulla TS, Rao JR, Yadav SS, Bharekar VV, Rajput MP. Development and validation of HPLC method for simultaneous quantitation of paracetamol and dexketoprofen trometamol in bulk drug and formulation. Pharm Glob. 2011;7:1-4.
  • 15. Ankush JP, Datar PA, Kedar TR, Kardile DP, Shete RV. Analytical method development and validation of thiocolchicoside and ibuprofen in tablet dosage form by UV spectrophotometry method. Res J Pharm Technol. 2021;14(2):981-985. [CrossRef]
  • 16. Vanparia D, Shah SA, Marolia BP, Bodiwala KB, Ptadia RK. Spectrophotometric methods for simultaneous estimation of thiocolchicoside and diclofenac sodium in their combined dosage form. Asian J Chem. 2011;4(1):123-127.
  • 17. Albayrak M, Demirkaya Miloğlu F, Şenol O, Polatdemir E. Design, optimization, and validation of chemometrics-assisted spectrophotometric methods for simultaneous determination of etodolac and thiocolchicoside in pharmaceuticals. J Anal Sci Technol. 2019;10(1):1-8.
  • 18. Jadhav SD, Butle SR, Patil SD, Jagtap PK. Validated stability indicating RP-HPLC method for simultaneous determination and in vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arab J Chem. 2015;8(1):118-128. [CrossRef]
  • 19. Chitlange SS, Shinde PS, Pawbake GR, Wankhede SB. Simultaneous estimation of thiocolchicoside and aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Pharm Lett. 2010;2(2):86-93
  • 20. Tank PK, Shah RR, Shukla MH, Nayak PP, Patel AP. Development and validation of first order derivative spectroscopic method for simultaneous estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form. Pharma Science Monitor. 2012;3(4):0976-7908.
  • 21. Bhavsar A, Joshi T, Vikani K, Senta A. Development and validation of UV-Visible spectrophotometric method for simultaneous estimation of ketoprofen and thiocolchicoside in solid oral dosage form. Int Res J Pharm. 2016;7(5):53-58. [CrossRef]
  • 22. Wankhede SB, Zambare SS, Chitlange SS. Estimation of thiocolchicoside and ketoprofen in pharmaceutical dosage form by spectrophotometric methods. J Pharm Res. 2010;3:34-39.
  • 23. Joshi T, Bhavsar A, Senta A. Development and Validation of spectrophotometric Method for Simultaneous Estimation of ketoprofen and thiocolchicoside in combined Solid Oral Dosage Form. Int J Pharm Life Sci. 2016;7(4):4979-4986.
  • 24. Trivedi SA, Joshi DM, Patel SG, Patel AJ. Optimization of mobile phase of high performance liquid chromatography using full factorial design for simultaneous estimation of thiocolchicoside and dexketoprofen trometamol in tablets. Biquarterly Iran J Anal Chem. 2015;2(1):14-21.
  • 25. Dhaneshwar SR, Jagtap VN. Development and validation of RPHPLC- PDA method for simultaneous determination of dexketoprofen and thiocolchicoside in pharmaceutical dosage form. J Pharm Res. 2013;6(6):604-608. [CrossRef]
  • 26. Wankhede SB, Zambare SS, Dixit NR, Chitlange SS. RP-HPLC method for simultaneous estimation of thiocolchicoside and ketoprofen in combined dosage form. Pharm Lett. 2010;2(3):315-320.
  • 27. Wankhede SB, Chitlange SS, Bhole RP, Zambare SS. A simple and sensitive HPTLC method for simultaneous analysis of thiocolchicoside and ketoprofen in combined dose tablet formulation. Anal Chem Lett. 2012;2(5):301-308. [CrossRef] 28. Patil VK, Gawad JB, Mhaske AJ. Simultaneous estimation of thin layer liquid chrom atogr aphy/ densi tomet ry method for thiocolchicoside and dexketoprofen in bulk and in tablet dosage form. J Appl Chem. 2013;2(4):913-921.
  • 29. Demirkaya AK, Demirkaya Miloglu F, Senol O. UV-vis spect ropho tomet ric-a ssist ed chemometric calibration models for simultaneous determination of thiamine and pyridoxine vitamins in powdered infant formula. Maced Pharm Bull. 2021;67(2):33-41.
  • 30. Fares MY, Abdelwahab NS, Hegazy MA, Abdelrahman MM, El-Sayed GM. Comparative chemometric manipulations of UVspectrophotometric data for the efficient resolution and determination of overlapping signals of cyclizine and its impurities in its pharmaceutical preparations. J AOAC Int. 2022;106(1):228-238.
  • 31. Keithley RB, Wightman RM, Heien ML. Multivariate concentration determination using principal component regression with residual analysis. Trends Analyt Chem. 2009;28(9):1127-1136.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences (Other)
Journal Section Research Articles
Authors

Nagihan KARAGÖL 0000-0001-9173-6571

Fatma DEMİRKAYA MİLOĞLU 0000-0001-5729-7181

Publication Date October 9, 2023
Published in Issue Year 2023 Volume: 3 Issue: 4

Cite

EndNote KARAGÖL N, DEMİRKAYA MİLOĞLU F (October 1, 2023) Simultaneous Spectrophotometric Determination of Dexketoprofen Trometamol and Thiocolchicoside by Using Principal Component Regression Multivariate Calibration Model in Combined Pharmaceutical Formulation. Pharmata 3 4 99–104.

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