Skip to main content
SpringerLink
Log in

Smart TLC–densitometric methods for determination of ophthalmic ternary mixture containing chloramphenicol in the presence of its synthetic precursor: Comparative eco-scaling for greenness assessment

  • Original Research Paper
  • Published:
JPC – Journal of Planar Chromatography – Modern TLC Aims and scope Submit manuscript

Abstract

Green analytical methods have gained a growing interest in the field of pharmaceutical research to reduce impacts on the environment and enhance analysts’ health safety. Chloramphenicol (CHL), dexamethasone sodium phosphate (DSP) and tetrahydrozoline HCl (THZ) form an ophthalmic ternary mixture that is co-formulated for conjunctivitis treatment. In the present work, for time saving and higher sensitivity, two green thin-layer chromatography (TLC) methods were developed for the determination of this ophthalmic ternary mixture in the absence or presence of p-nitroacetophenone (PNA), a synthetic precursor of chloramphenicol. In both proposed methods, silica gel 60 F254 plates were used as the stationary phase. The mobile phase used for method (A) was ethanol‒water‒ammonia (7.0:2.5:0.5, V/V), while, for method (B), acetonitrile‒water‒ammonia (10.0:3.0:0.5, V/V) was used as the mobile phase. TLC separation was followed by quantitative determination of the aforementioned drugs at wavelengths 242.0 nm and 220.0 nm. Both methods were validated in compliance with the International Conference on Harmonisation (ICH) guidelines, where both methods were found to be reliable, reproducible, and selective. Statistical comparison of the developed methods was done with a reported high-performance liquid chromatography (HPLC) method where no significant difference was found. Analytical eco-scaling depends on penalty point which was calculated to be 92, 88 and 87 for methods A, B and the reported HPLC, respectively, suggesting that the proposed methods are eco-friendlier with penalty point scoring very high on the scale than the reported one.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Welch JC, Wu N, Biba M, Hartman R et al (2010) Greening analytical chromatography. Trends Anal Chem 29:667–680. https://doi.org/10.1016/j.trac.2010.03.008

    Article  CAS  Google Scholar 

  2. Lamie NT, Mohamed HM (2015) Application and validation of an eco-friendly TLC–densitometric method for simultaneous determination of co-formulated antihypertensive. RSC Adv 5:59048–59055. https://doi.org/10.1039/C5ra08125d

    Article  CAS  Google Scholar 

  3. Abdelaleem EA, Abdelwaha NS (2018) Green chromatographic method for analysis of some anti-cough drugs and their toxic impurities with comparison to conventional methods. Saudi Pharm J 26:1185–1191. https://doi.org/10.1016/J.Jsps.2018.07.007

    Article  PubMed  PubMed Central  Google Scholar 

  4. Attimarad M, Ahmed M, Aldhubaib BE et al (2011) High-performance thin layer chromatography: a powerful analytical technique in pharmaceutical drug discovery. Pharm Methods 2:71–75

    Article  Google Scholar 

  5. Zlatkis A, Kaiser RE (eds) (1977) HPTLC–high-performance thin-layer chromatography. Elsevier Science, Amsterdam

    Google Scholar 

  6. Rathore AS, Lohidasan S, Mahadik KR (2010) Development of validated HPLC and HPTLC methods for simultaneous determination of levocetirizinedihydrochloride and montelukast sodium in bulk drug and pharmaceutical dosage form. Pharm Anal Acta 1:2–6. https://doi.org/10.4172/2153-2435.1000106

    Article  CAS  Google Scholar 

  7. Michael AM, Fayez YM, Nessim CK, Lotfy HM (2016) Densitometric methods for the analysis of mebeverine hydrochloride and chlordiazepoxide in their binary mixture. Eur J Chem 7:315–321. https://doi.org/10.5155/eurjchem.7.3.315-321.1468

    Article  CAS  Google Scholar 

  8. Janumala H, Kumar P, Baran A (2012) Bacterial keratitis – causes, symptoms and treatment. In: Srinivasan M (ed) Keratit is. IntechOpen, London, pp 16–28. https://doi.org/10.5772/34599

    Chapter  Google Scholar 

  9. Hamoudi TA, Bashir WA (2018) Spectrophotometric determination of chloramphenicol in pharmaceutical preparations. J Educ Sci 27:19–35

    Article  Google Scholar 

  10. Al-Rimawi F, Kharoaf M (2011) Analysis of chloramphenicol and its related compound 2-amino-1-(4-nitrophenyl)propane-1,3-diol by reversed-phase high-performance liquid chromatography with UV detection. Chromatogr Res Int 2011:1–6. https://doi.org/10.4061/2011/482308

    Article  CAS  Google Scholar 

  11. Henderer JD, Rapuano CJ (2006) Ocular pharmacology. In: Brunton LL, Chabner BA (eds) Goodman & Gilman’s – The pharmacological basis of therapeutics, 11th edn. McGraw-Hill, New York, NY, pp 1707–1737

    Google Scholar 

  12. Chen SNQ, Zielinski D, Chen J, Koski A et al (2008) A validated stability-indicating HPLC method for the determination of dexamethasone related substances on dexamethasone-coated drug-eluting stents. J Pharm Biomed Anal 48(3):732–8. https://doi.org/10.1016/j.jpba.2008.07.010

    Article  CAS  PubMed  Google Scholar 

  13. Cuvillo AV, Sastre J, Montoro J et al (2009) Allergic conjunctivitis and H1 antihistamines. J Investig Allergol Clin Immunol 19(1):11–18

    PubMed  Google Scholar 

  14. Tripathi KD (1999) Essentials of medical pharmacology, 4th edn, p 179. Jaypee Brothers Medical Publishers, New Delhi

    Google Scholar 

  15. Long LM, Troutman HD (1949) Chloramphenicol1 (chloromycetin). VII. Synthesis through p-Nitroacetophenone. J Am Chem Soc 71:2473–2475. https://doi.org/10.1021/ja01175a068

    Article  CAS  Google Scholar 

  16. Collins RJ, Ellis B, Hansen SB, et al (1952) Some observations on the structural requirements for antibiotic activity in the chloramphenicol series, Part II. J Pharm Pharmacol 4:693–710. https://doi.org/10.1111/j.2042-7158.1952.tb13204.x

    Article  CAS  PubMed  Google Scholar 

  17. Lotfy HM, Saleh SS, Hassan YN, Salem H (2014) A Comparative study of novel spectrophotometric methods based on isosbestic points; application on a pharmaceutical ternary mixture. Spectrochim Acta 126:112–121. https://doi.org/10.1016/J.Saa.2014.01.130

    Article  CAS  Google Scholar 

  18. Saleh SS, Lotfy HM, HassanYN SH (2014) A comparative study of progressive versus successive spectrophotometric resolution techniques applied for pharmaceutical ternary mixtures. Spectrochim Acta 132:239–248. https://doi.org/10.1016/J.Saa.2014.05.004

    Article  CAS  Google Scholar 

  19. Salem H, Hassan NY, Lotfy HM, Saleh SS (2015) Column performance study of different variants of liquid chromatographic technique: an application on pharmaceutical ternary mixtures containing tetryzoline. J Chromatogr Sci 53:708–715. https://doi.org/10.1093/Chromsci/Bmu109

    Article  CAS  PubMed  Google Scholar 

  20. Alaani H, Alnukkary Y (2016) Stability-indicating HPLC method for simultaneous determination of chloramphenicol, dexamethasone sodium phosphate and tetrahydrozoline hydrochloride in ophthalmic solution. Adv Pharm Bull 6:137–141. https://doi.org/10.15171/Apb.2016.020

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Alaani H, Alnukkary Y, Alashkar I (2014) Stability and kinetic studies for the estimation of shelf life of chloramphenicol, dexamethasone sodium phosphate, and tetrahydrozoline hydrochloride ophthalmic solution. Int J Pharm Sci Rev Res 57:327–330

    Google Scholar 

  22. Hassan NY, Lotfy HM, Saleh SS, Salem H (2015) Development of membrane electrodes for the specific determination of tetryzoline hydrochloride in presence of its degradation product in pharmaceutical formulations and biological fluids. Anal Bioanal Electrochem 7(1):75–90

    CAS  Google Scholar 

  23. Gałuszka A, Migaszewski ZM, Konieczka P, Namiesnik J (2012) Analytical eco-scale for assessing the greenness of analytical procedures. Trends Anal Chem 37:61–72. https://doi.org/10.1016/J.Trac.2012.03.013

    Article  Google Scholar 

  24. British Pharmacopoeia Commission (2012) British Pharmacopoeia, vol 2. Stationery Office, London

    Google Scholar 

  25. Pyka A, Babuska M, Bober K, Gurak D, Klimczok W, Miszczyk M (2006) Influence of temperature of silica gel activation on separation of selected biologically active steroid compounds. J Liq Chromatogr Relat Technol 29:2035–2044. https://doi.org/10.1080/10826070600758449

    Article  CAS  Google Scholar 

  26. Chaban VV, Maciel C, Fileti EE (2014) Does the like dissolves like rule hold for fullerene and ionic liquids? J Sol Chem 43:1019–1031. https://doi.org/10.1007/s10953-014-0155-6

    Article  CAS  Google Scholar 

  27. International Conference on Harmonisation (2003) ICH Q1A(R2) Harmonised tripartite guideline, stability testing of new drug substances and products. Geneva

  28. Al-Alamein AMA, El-Rahman MKA, Abdel-Moety EM, Fawaz EM (2019) Green HPTLC–densitometric approach for simultaneous determination and impurity – profiling of ebastine and phenylephrine hydrochloride. Microchem J 147:1097–1102. https://doi.org/10.1016/j.microc.2019.04.043

    Article  CAS  Google Scholar 

  29. Tobiszewski M (2015) Green chemistry metrics with special reference to green analytical chemistry. Molecules 20:10928–10946. https://doi.org/10.3390/molecules200610928

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. Mohamed HM, Lami NT (2016) Analytical eco-scale for assessing the greenness of a developed RP-HPLC method used for simultaneous analysis of combined antihypertensive medications. J AOAC Int 99:1260–1265. https://doi.org/10.5740/Jaoacint.16-0124

    Article  CAS  PubMed  Google Scholar 

  31. Dias LD, Gonçalves KHE, Queiroz JE, Vila GM et al (2018) An eco-friendly and alternative method of forced degradation of fluoroquinolone drugs by microwave irradiation : a new application for analytical eco-scale. J Microw Power Electromagn Energy 52:162–181. https://doi.org/10.1080/08327823.2018.1494470

    Article  Google Scholar 

  32. Tobiszewski M (2016) Analytical methods metrics for green analytical chemistry. Anal Methods 8:2993–2999. https://doi.org/10.1039/C6ay00478d

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors would like to express their gratitude to Egyptian International Pharmaceutical Industries Co and Orchidia Company, Cairo, Egypt, for donating pure chloramphenicol, dexamethasone sodium phosphate and tetrahydrozoline HCl samples.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sector.

Author information

Authors and Affiliations

  1. Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo, 11829, Egypt

    Maya S. Eissa & Heidi R. Abd El-Hadi

  2. Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, Cairo, 11562, Egypt

    Hala E. Zaazaa & Basma M. Eltanany

Authors
  1. Maya S. Eissa
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Heidi R. Abd El-Hadi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Hala E. Zaazaa
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Basma M. Eltanany
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Maya S. Eissa.

Ethics declarations

Conflict of interest

There are no conflicts of interest to declare.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Eissa, M.S., Abd El-Hadi, H.R., Zaazaa, H.E. et al. Smart TLC–densitometric methods for determination of ophthalmic ternary mixture containing chloramphenicol in the presence of its synthetic precursor: Comparative eco-scaling for greenness assessment. JPC-J Planar Chromat 33, 501–509 (2020). https://doi.org/10.1007/s00764-020-00055-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00764-020-00055-8

Keywords

Search

Navigation