Research Article
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Year 2018, Volume: 5 Issue: 2, 763 - 774, 01.01.2018
https://doi.org/10.18596/jotcsa.403497

Abstract

References

  • 1. Sorouraddin MH, Saadati M, Mirabi F. Simultaneous determination of some common food dyes in commercial products by digital image analysis. Journal of Food and Drug Analysis. (2015); 23(3): 447-452. DOI: 10.1016/j.jfda.2014.10.007.
  • 2. Grosa G, Del Grosso E, Russo R, Allegrone G. Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. Journal of Pharmaceutical and Biomedical Analysis. 2006;41:798-803. DOI: 10.1016/j.jpba.2006.01.026.
  • 3. Baranowska I, Wojciechowska I, Solarz N, Krutysza E. Determination of preservatives in cosmetics, cleaning agents and pharmaceuticals using fast liquid chromatography. Journal of Chromatographic Science. 2013;52:88-94. DOI: 10.1093/chromsci/bms210.
  • 4. Yang J, Li Y, Gong W, Wang C, Liu B, Sun C. Simultaneous determination of six parabens in foods by matrix liquid-phase dispersion extraction combined with high-performance liquid chromatography. Food Analytical Methods. 2014;7:1693-702. DOI: 10.1007/s12161-014-9807-9.
  • 5. Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicology and Applied Pharmacology. 1998;153: 12-19. DOI: 10.1006/taap.1998.8544.
  • 6. Shanmugam G, Ramaswamy BR, Radhakrishnan V, Tao H. GC–MS method for the determination of paraben preservatives in the human breast cancerous tissue, Microchemical Journal. 2010; 96: 391–396. DOI: 10.1016/j.microc.2010.07.005.
  • 7. Wang W, Wang Y, Zhang J, Chu Q, Ye J. Simultaneous determination of electroactive and non-electroactive food preservatives by novel capillary electrophoresis with amperometric detection. Analytica Chimica Acta. 2010; 678:39-43. DOI: 10.1016/j.aca.2010.08.018.
  • 8. Pagáčiková D, Lehotay J. Determination of synthetic colors in meat products using high-performance liquid chromatography with photodiode array detector. Journal of Liquid Chromatography & Related Technologies. 2015;38:579-583. DOI: 10.1080/10826076.2014.922473.
  • 9. Martin F, Oberson JM, Meschiari M, Munari C. Determination of 18 water-soluble artificial dyes by LC–MS in selected matrices. Food Chemistry. 2016;197:1249-1255. DOI: 10.1016/j. foodchem.2015.11.067.
  • 10. Davletbaeva P, Chocholouš P, Bulatov A, Šatínský D, Solich P. Sub–1 min separation in sequential injection chromatography for determination of synthetic water-soluble dyes in pharmaceutical formulation. Journal of Pharmaceutical and Biomedical Analysis. 2017; 143: 123-129. DOI: 10.1016/j.jpba.2017.05.036.
  • 11. The European Parliament, Regulation (EC) No 1333/2008 of the European Parliament and of The Council of 16 December 2008 on food additives, Official Journal of the European Union, No 1333/2008.
  • 12. EFSA (European Food Safety Authority) (2009) The EFSA Journal 7: 1328-67.
  • 13. Aksu Dönmez Ö, Aşçı B, Dinç-Zor Ş, Aslan Çakır A. Simultaneous quantitative analysis of ephedrine HCl, guaifenesin, and some synthetic additives in syrups by RP-HPLC using Box-Behnken design. Latin American Journal of Pharmacy. 2018; 37: 85-94 (2018).
  • 14. Lokhnauth JK, Snow NH. Determination of parabens in pharmaceutical formulations by solid-phase microextraction-ion mobility spectrometry. Analytical Chemistry. 2005;77:5938-5946. DOI: 10.1021/ac0504013.
  • 15. Rebbeck C, Hammond R, Wong J, Nair L, Raghavan N, Hepler D, Campbell W, Lynn, R. Solid-phase extraction and HPLC analysis of methylparaben and propylparaben in a concentrated antibiotic suspension. Drug Development and Industrial Pharmacy. 2006; 32:1095-1102. DOI: 10.1080/03639040600713050.
  • 16. Bosch ME, Sánchez AR, Rojas FS, Ojeda CB. Determination of paracetamol: Historical evolution. Journal of Pharmaceutical and Biomedical Analysis. 2006;42:291-321. DOI: 10.1016/j.jpba.2006.04.007.
  • 17. Dinç Ş, Aksu Dönmez Ö, Aşçı B, Bozdoğan AE. Chromatographic and chemometrics-assisted spectrophotometric methods for the simultaneous determination of allobarbital, adiphenine hydrochloride, and paracetamol in suppository. Journal of Liquid Chromatography & Related Technologies. 2014;37:560-571. DOI: 10.1080/10826076.2012.749498.
  • 18. Tzanavaras P, Karakosta T, Rigas P, Themelis D, Zotou A. Isocratic liquid chromatographic determination of three paraben preservatives in hygiene wipes using a reversed phase core-shell narrow-bore column. Open Chemistry. 2012;10:1459-1463. DOI: 10.2478/s11532-012-0091-5.
  • 19. Kumar S, Mathkar S, Romero C, Rustum AM. Development and validation of a single RP-HPLC assay method for analysis of bulk raw material batches of four parabens that are widely used as preservatives in pharmaceutical and cosmetic products. Journal of Chromatographic Science. 2011;49: 405-411. DOI:10.1093/chromsci/49.5.405.
  • 20. Rovina K, Acung LA, Siddiquee S, Akanda JH, Shaarani SM. Extraction and analytical methods for determination of sunset yellow (E110)—a Review. Food Analytical Methods. 2017;10:773-787. DOI: 10.1007/s12161-016-0645-9.
  • 21. Rejczak T, Tuzimski T. Application of high-performance liquid chromatography with diode array detector for simultaneous determination of 11 synthetic dyes in selected beverages and foodstuffs. Food Analytical Methods. 2017;10: 3572-3588. DOI: 10.1007/s12161-017-0905-3.
  • 22. Khanavi M, Hajimahmoodi M, Ranjbar AM, Oveisi MR, Ardekani MRS, Mogaddam G. Development of a green chromatographic method for simultaneous determination of food colorants. Food Analytical Methods. 2012;5:408-415. DOI: 10.1007/s12161-011-9259-4.
  • 23. Yamjala K, Nainar MS, Ramisetti NR. Methods for the analysis of azo dyes employed in food industry–a review. Food Chemistry. 2016;192:813-824. DOI:10.1016/j.foodchem.2015.07.085.
  • 24. Hasan N, Chaiharn M, Toor UA, Mirani ZA, Sajjad G, Sher N, Aziz M, Siddiqui FA Development, validation and application of RP-HPLC method: Simultaneous determination of antihistamine and preservatives with paracetamol in liquid formulations and human serum. Open Medicinal Chemistry Journal, (2016); 10:33-43. DOI: 10.2174/1874104501610010033.
  • 25. Abd El-Hay SS, Mohram MS. Development and validation of new RP-HPLC method for simultaneous determination of methyl and propyl parabens with levetiracetam in pure form and pharmaceutical formulation. Chromatography Research International. 2016. DOI: 10.1155/2016/4909547.
  • 26. Weshahy SAEF, Yaaqob MS, Morcos MN, Hassan DW, Youssef NF. Simultaneous determinatıon of levodropropizine, methylparaben, and propylparaben in oral co-formulated syrup by RP-HPLC method. Journal of the Chilean Chemical Society. 2015;60: 2729-2733. DOI: 10.4067/S0717-97072015000400018.
  • 27. Ali MS, Ghori M, Khatri AR. Stability indicating simultaneous determination of domperidone (DP), methylparaben (MP) and propylparaben by high performance liquid chromatography (HPLC). Journal of Pharmaceutical and Biomedical Analysis. 2006; 41:358-365. DOI: 10.1016/j.jpba.2005.12.026.
  • 28. International Conference on Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures-Test and Methodology, Geneva, Switzerland, 2005.

A Facile HPLC-PDA Method for Simultaneous Determination of Paracetamol, Methyl Paraben, Sunset Yellow and Carmosine in Oral Suspensions

Year 2018, Volume: 5 Issue: 2, 763 - 774, 01.01.2018
https://doi.org/10.18596/jotcsa.403497

Abstract

In the present study, a simple, fast
and accurate HPLC-PDA method was developed for the simultaneous determination
of paracetamol (PAR), methylparaben (MP), sunset yellow (SSY) and carmoisine
(CAR) in oral suspensions. The concentrations of colorants are less than with
respect to those of active ingredient and this variation makes process of
analysis toublesome. In the developed HPLC method, efficient chromatographic
separation was achieved using reversed phase C18 column (4.6 mm x 150 mm x 5 μm
particle size) and phosphate buffer solution (pH = 6.5)-acetonitrile mobile
phase with a flow rate of 1.6 mL/min in the gradient mode. The eluents were
monitored via a PDA detector at 300, 254 and 230 nm. The mean retention times of
SSY, PAR, CAR and MP were found to be 1.58, 2.15, 3.81 and 4.42, respectively.
The proposed method was validated in accordance with ICH guidelines and it was
seen that the method met all requirements in terms of linearity, precision,
accuracy and selectivity. The developed method was successfully applied for
simultaneous determination of the studied compounds in two commercial oral
suspension samples. 

References

  • 1. Sorouraddin MH, Saadati M, Mirabi F. Simultaneous determination of some common food dyes in commercial products by digital image analysis. Journal of Food and Drug Analysis. (2015); 23(3): 447-452. DOI: 10.1016/j.jfda.2014.10.007.
  • 2. Grosa G, Del Grosso E, Russo R, Allegrone G. Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. Journal of Pharmaceutical and Biomedical Analysis. 2006;41:798-803. DOI: 10.1016/j.jpba.2006.01.026.
  • 3. Baranowska I, Wojciechowska I, Solarz N, Krutysza E. Determination of preservatives in cosmetics, cleaning agents and pharmaceuticals using fast liquid chromatography. Journal of Chromatographic Science. 2013;52:88-94. DOI: 10.1093/chromsci/bms210.
  • 4. Yang J, Li Y, Gong W, Wang C, Liu B, Sun C. Simultaneous determination of six parabens in foods by matrix liquid-phase dispersion extraction combined with high-performance liquid chromatography. Food Analytical Methods. 2014;7:1693-702. DOI: 10.1007/s12161-014-9807-9.
  • 5. Routledge EJ, Parker J, Odum J, Ashby J, Sumpter JP. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicology and Applied Pharmacology. 1998;153: 12-19. DOI: 10.1006/taap.1998.8544.
  • 6. Shanmugam G, Ramaswamy BR, Radhakrishnan V, Tao H. GC–MS method for the determination of paraben preservatives in the human breast cancerous tissue, Microchemical Journal. 2010; 96: 391–396. DOI: 10.1016/j.microc.2010.07.005.
  • 7. Wang W, Wang Y, Zhang J, Chu Q, Ye J. Simultaneous determination of electroactive and non-electroactive food preservatives by novel capillary electrophoresis with amperometric detection. Analytica Chimica Acta. 2010; 678:39-43. DOI: 10.1016/j.aca.2010.08.018.
  • 8. Pagáčiková D, Lehotay J. Determination of synthetic colors in meat products using high-performance liquid chromatography with photodiode array detector. Journal of Liquid Chromatography & Related Technologies. 2015;38:579-583. DOI: 10.1080/10826076.2014.922473.
  • 9. Martin F, Oberson JM, Meschiari M, Munari C. Determination of 18 water-soluble artificial dyes by LC–MS in selected matrices. Food Chemistry. 2016;197:1249-1255. DOI: 10.1016/j. foodchem.2015.11.067.
  • 10. Davletbaeva P, Chocholouš P, Bulatov A, Šatínský D, Solich P. Sub–1 min separation in sequential injection chromatography for determination of synthetic water-soluble dyes in pharmaceutical formulation. Journal of Pharmaceutical and Biomedical Analysis. 2017; 143: 123-129. DOI: 10.1016/j.jpba.2017.05.036.
  • 11. The European Parliament, Regulation (EC) No 1333/2008 of the European Parliament and of The Council of 16 December 2008 on food additives, Official Journal of the European Union, No 1333/2008.
  • 12. EFSA (European Food Safety Authority) (2009) The EFSA Journal 7: 1328-67.
  • 13. Aksu Dönmez Ö, Aşçı B, Dinç-Zor Ş, Aslan Çakır A. Simultaneous quantitative analysis of ephedrine HCl, guaifenesin, and some synthetic additives in syrups by RP-HPLC using Box-Behnken design. Latin American Journal of Pharmacy. 2018; 37: 85-94 (2018).
  • 14. Lokhnauth JK, Snow NH. Determination of parabens in pharmaceutical formulations by solid-phase microextraction-ion mobility spectrometry. Analytical Chemistry. 2005;77:5938-5946. DOI: 10.1021/ac0504013.
  • 15. Rebbeck C, Hammond R, Wong J, Nair L, Raghavan N, Hepler D, Campbell W, Lynn, R. Solid-phase extraction and HPLC analysis of methylparaben and propylparaben in a concentrated antibiotic suspension. Drug Development and Industrial Pharmacy. 2006; 32:1095-1102. DOI: 10.1080/03639040600713050.
  • 16. Bosch ME, Sánchez AR, Rojas FS, Ojeda CB. Determination of paracetamol: Historical evolution. Journal of Pharmaceutical and Biomedical Analysis. 2006;42:291-321. DOI: 10.1016/j.jpba.2006.04.007.
  • 17. Dinç Ş, Aksu Dönmez Ö, Aşçı B, Bozdoğan AE. Chromatographic and chemometrics-assisted spectrophotometric methods for the simultaneous determination of allobarbital, adiphenine hydrochloride, and paracetamol in suppository. Journal of Liquid Chromatography & Related Technologies. 2014;37:560-571. DOI: 10.1080/10826076.2012.749498.
  • 18. Tzanavaras P, Karakosta T, Rigas P, Themelis D, Zotou A. Isocratic liquid chromatographic determination of three paraben preservatives in hygiene wipes using a reversed phase core-shell narrow-bore column. Open Chemistry. 2012;10:1459-1463. DOI: 10.2478/s11532-012-0091-5.
  • 19. Kumar S, Mathkar S, Romero C, Rustum AM. Development and validation of a single RP-HPLC assay method for analysis of bulk raw material batches of four parabens that are widely used as preservatives in pharmaceutical and cosmetic products. Journal of Chromatographic Science. 2011;49: 405-411. DOI:10.1093/chromsci/49.5.405.
  • 20. Rovina K, Acung LA, Siddiquee S, Akanda JH, Shaarani SM. Extraction and analytical methods for determination of sunset yellow (E110)—a Review. Food Analytical Methods. 2017;10:773-787. DOI: 10.1007/s12161-016-0645-9.
  • 21. Rejczak T, Tuzimski T. Application of high-performance liquid chromatography with diode array detector for simultaneous determination of 11 synthetic dyes in selected beverages and foodstuffs. Food Analytical Methods. 2017;10: 3572-3588. DOI: 10.1007/s12161-017-0905-3.
  • 22. Khanavi M, Hajimahmoodi M, Ranjbar AM, Oveisi MR, Ardekani MRS, Mogaddam G. Development of a green chromatographic method for simultaneous determination of food colorants. Food Analytical Methods. 2012;5:408-415. DOI: 10.1007/s12161-011-9259-4.
  • 23. Yamjala K, Nainar MS, Ramisetti NR. Methods for the analysis of azo dyes employed in food industry–a review. Food Chemistry. 2016;192:813-824. DOI:10.1016/j.foodchem.2015.07.085.
  • 24. Hasan N, Chaiharn M, Toor UA, Mirani ZA, Sajjad G, Sher N, Aziz M, Siddiqui FA Development, validation and application of RP-HPLC method: Simultaneous determination of antihistamine and preservatives with paracetamol in liquid formulations and human serum. Open Medicinal Chemistry Journal, (2016); 10:33-43. DOI: 10.2174/1874104501610010033.
  • 25. Abd El-Hay SS, Mohram MS. Development and validation of new RP-HPLC method for simultaneous determination of methyl and propyl parabens with levetiracetam in pure form and pharmaceutical formulation. Chromatography Research International. 2016. DOI: 10.1155/2016/4909547.
  • 26. Weshahy SAEF, Yaaqob MS, Morcos MN, Hassan DW, Youssef NF. Simultaneous determinatıon of levodropropizine, methylparaben, and propylparaben in oral co-formulated syrup by RP-HPLC method. Journal of the Chilean Chemical Society. 2015;60: 2729-2733. DOI: 10.4067/S0717-97072015000400018.
  • 27. Ali MS, Ghori M, Khatri AR. Stability indicating simultaneous determination of domperidone (DP), methylparaben (MP) and propylparaben by high performance liquid chromatography (HPLC). Journal of Pharmaceutical and Biomedical Analysis. 2006; 41:358-365. DOI: 10.1016/j.jpba.2005.12.026.
  • 28. International Conference on Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures-Test and Methodology, Geneva, Switzerland, 2005.
There are 28 citations in total.

Details

Primary Language English
Subjects Electrochemistry
Journal Section Articles
Authors

Şule Dinç Zor 0000-0002-9703-6768

Özlem Aksu Dönmez This is me 0000-0001-5445-6247

Publication Date January 1, 2018
Submission Date March 9, 2018
Acceptance Date May 6, 2018
Published in Issue Year 2018 Volume: 5 Issue: 2

Cite

Vancouver Dinç Zor Ş, Aksu Dönmez Ö. A Facile HPLC-PDA Method for Simultaneous Determination of Paracetamol, Methyl Paraben, Sunset Yellow and Carmosine in Oral Suspensions. JOTCSA. 2018;5(2):763-74.