Two eco-friendly spectrophotometric methods for the concurrent estimation of diacerein and meloxicam: greenness and whiteness assessment

Document Type : Original Article

Authors

1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.

2 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt.

3 Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt.

Abstract

The current study represents the concurrent analysis of diacerein and meloxicam in their binary mixture by two simple spectrophotometric methods, for the first time without prior separation, namely the dual-wavelength and the zero-crossing derivative spectrophotometry methods. Firstly, the dual wavelength method involves the selection of two wavelengths at the original absorption spectra for each drug in such a way that the subtraction of absorbance readings equals zero for the second drug. Wavelengths at 256.0 and 308.5 nm were chosen for the estimation of diacerein where meloxicam showed equal absorption values. Similarly, wavelengths at 357.0 and 281.0 nm were selected for the determination of meloxicam without any contribution of diacerein. Secondly, the other method depends on derivative spectrophotometry with zero-crossing measurement to solve the spectral overlap problem where diacerein was easily assayed using 2D amplitudes at 265.5 nm with no contribution from meloxicam.
Also, meloxicam was determined by calculating the sum of the absolute values of 1D amplitudes at 339 and 395 nm, where diacerein was zero-crossing at these wavelengths. The ICH guidelines were used to validate the analytical performance of the adopted methods. For the two adopted methods, diacerein and meloxicam showed perfect linearities in the ranges 2-14 µg/mL and 3-24 µg/mL, respectively, with high correlation coefficients (≥ 0.99975). The validated procedures were effectively used in the concurrent quantification of both drugs either in bulk powders, synthetic mixtures, or laboratory-prepared capsules. Finally, the greenness and whiteness of the adopted methods were assessed and compared among other reported procedures. 

Highlights

  • Two spectrophotometric methods named the dual wavelength and zero-crossing derivative spectrophotometry techniques were investigated for the concurrent estimation of DCN and MLX in their combined formulation.
  • The developed methods were validated in accordance with ICH guidelines and can be easily applied for the determination of this binary mixture in quality control units.
  • The suggested methods possess greenness and whiteness properties according to GAPI, AGREE, and RGB approaches.

Keywords

Main Subjects

References

  1. Tamura T, Shirai T, Kosaka N, Ohmori K, Takafumi N. Pharmacological studies of diacerein in animal models of inflammation, arthritis and bone resorption. Eur. J. Pharmacol. 2002; 448 (1): 81–87.
  2. Louthrenoo W, Nilganuwong S, Aksaranugraha S, Asavatanabodee P, Saengnipanthkul S, the Thai Study Group. The efficacy, safety, and carry-over effect of diacerein in the treatment of painful knee osteoarthritis: a randomised, double-blind, NSAID-controlled study. Osteoarthr. Cartil. 2007; 15 (6): 605–614.
  3. Dwicandra, NMO, Jaya, MKA. The effect of diacerein and meloxicam combination versus meloxicam alone on physical function in patients with knee osteoarthritis. Asian J. Pharmaceut. Clin. Res. 2018; 11: 325–329.
  4. Dwicandra, NMO, Setiadi, AAP. Comparison of pain score in osteoarthritis patients treated with a combination of diacerein and meloxicam and meloxicam alone. Int. J. Pharm. Pharmaceut. Sci. 2017; 9: 69–73.
  5. https://go.drugbank.com/drugs/DB00814.
  6. Gadotti VM, Martins DF, Pinto HF, Oliveira G, Kaster MP, Quint˜ao NLM, A. Santos ARS. Diacerein decreases visceral pain through inhibition of glutamatergic neurotransmission and cytokine signaling in mice, Pharmacol. Biochem. Behav. 2012; 102 (4): 549–554.
  7. Fidelix TSA, Macedo CR, Maxwell LJ. Diacerein for osteoarthritis, Cochrane Database Syst. Rev. 2006; 25(1): CD005117.
  8. Bindaiya S, Bankey S, Jain D. Simultaneous determination of nitazoxanide and ofloxacin in tablet by ultraviolet spectrophotometry (dual wavelength method). Int. J. Chemtech Res. 2010; 2(1): 11-15.
  9. Rezk MR, Monir HH, Marzouk HM. Spectrophotometric assessment of the brand new antiviral combination: Sofosbuvir and velpatasvir in their pure forms and pharmaceutical formulation. Spectrochim Acta A Mol Biomol Spectrosc. 2019; 213: 159–166.
  10. Hussein LA, Magdy N, Abbas MM. Five different spectrophotometric methods for determination of Amprolium hydrochloride and Ethopabate binary mixture. Spectrochim Acta A Mol Biomol Spectrosc. 2015; 138: 395–405.
  11. Erk N. Simultaneous determination of dorzolamide HCL and timolol maleate in eye drops by two different spectroscopic methods. J. Pharm. Biomed. Anal. 2002; 28: 391–397
  12. Abo-Gharam AH, El-Kafrawy DS, Abdel-Khalek MM, Mahrous MS, Belal TS. Spectrophotometric and Chromatographic Methods for Simultaneous Determination of Aspirin and Omeprazole. Anal. Chem. Lett. 2020; 10(2): 240-262.
  13. Kumar IK, Jayaprakash P, Reddy VS, Sriramulu J. stability indicating analytical method development and estimation of impurities in diacerein and meloxicam capsules by HPLC. Int. J. Pharmacother.2017; 7 (1).
  14. El-Kafrawy DS, Abo-Gharam AH, Abdel-Khalek MM, Belal TS. Comparative study of two versatile multi-analyte chromatographic methods for determination of diacerein together with four non-steroidal anti-inflammatory drugs: greenness appraisal using Analytical Eco-Scale and AGREE metrics. Sust. Chem. and Pharm. 2022; 28: article no. 100709 p.1-14.
  15. El-Kafrawy DS, El-Shoubashy OH, Issa AE, Beltagy YA. Sustainable multi-analyte HPTLC estimation of meloxicam, diclofenac and diacerein along with its major degradation product and official impurity; rhein: Comprehensive greenness and whiteness evaluation. Microchem. J. 2022; 193: article no.109098 p. 1-10.
  16. ICH, Q2A (R1), Validation of Analytical Procedures: Text and Methodology, International Council for Harmonization, 2005.
  17. Miller JN, Miller JC. “Statistics and Chemometrics for Analytical Chemistry”, 5th edition, Pearson Education Limited, Harlow, England, pp. 54-61, 2005.
  18. Płotka-Wasylka J. A new tool for the evaluation of the analytical procedure: green analytical procedure index. Talanta 2018; 181: 204–209.
  19. Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-analytical greenness metric approach and software. Anal. Chem. 2020; 92 (14): 10076–10082.
  20. Nowak PM, Wietecha-Posłuszny R, Pawliszyn J. White analytical chemistry: an approach to reconcile the principles of green analytical chemistry and functionality, TrAC Trends Anal. Chem. 2021; 138: article no.116223.

 

Files

Share

How to cite

Statistics