Amal M. Abou Al Alamein, Hanan A. Merey, Reem A. El Kalla, Ahmed Emad El Gendy
email@example.com , firstname.lastname@example.org , email@example.com , firstname.lastname@example.org
Amal M. Abou Al Alamein1*, Hanan A. Merey1, Reem A. El Kalla2*, Ahmed Emad El Gendy2
1Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El Aini, Cairo 11562, Egypt.
2Analytical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Misr-Ismailia Road, Cairo-Egypt.
Volume - 13,
Issue - 11,
Year - 2020
Four different selective, sensitive, precise and accurate UV spectrophotometric methods were developed and validated for simultaneous determination of binary mixture of sulphadoxine (SDX) and trimethoprim (TRM) in a veterinary pharmaceutical dosage form. The First method is the dual wavelength (DW-SM), which is based on measuring the difference in absorbance at two selected wavelengths (?A274.2 nm-299.5 nm) for determination of SDX and (?A238.1 nm-300.1 nm) for determination of TRM where the component of interest has a notable difference in absorbance and the other component shows zero absorbance at the same selected wavelengths, The second method is based on using derivative spectrophotometry. The first derivative spectrophotometric method (1D) was adapted for selective determination of SDX and TRM by measuring the peak amplitude at 289.2 nm and 230.5 nm, respectively. The third method is ratio difference spectrophotometric method (RD-SM) which is based on measuring the difference in peak amplitude of the ratio spectra at (?P260.7nm-229.5nm) for determination of SDX and (?P233.6nm-247.6nm) for determination of TRM. The fourth method depends on measuring the peak amplitude of the first derivative of ratio spectra (1DD) at 254.4 nm and 224 nm for determination of SDX and TRM, respectively. The proposed spectrophotometric methods were validated according to the ICH guidelines and applied successfully for simultaneous quantitative analysis for both drugs in pure form, laboratory prepared mixture and in their combined veterinary pharmaceutical dosage form. Statistical comparison was done between the obtained results and those obtained by the reported method, showing no significant difference with respect to accuracy and precision at p = 0.05.
Cite this article:
Amal M. Abou Al Alamein, Hanan A. Merey, Reem A. El Kalla, Ahmed Emad El Gendy. Validated Spectrophotometric Methods for Simultaneous Determination of Sulphadoxine and trimethoprim in a Veterinary Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2020; 13(11):5151-5157. doi: 10.5958/0974-360X.2020.00901.4
1. British Pharmacopoeia Commission, the British Pharmacopoeia. Vol. 2. 2016, London, UK: TSO.
2. Martindale, W. and S.C. Sweetman, Martindale: the complete drug reference. 33 ed. 2002, UK: pharmaceutical press.
3. National center for Biotechnology Information. Pubchem compound database; cid17134. Available from: http://pubchem.ncbi.nlm.nih.gov/compound/17134.
4. Onah, J.O. and J.E. Odeiani, Simultaneous spectrophotometric determination of sulfadoxine and pyrimethamine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis, 2002. 30(3): p. 851-857.
5. Meena, S. and S. Sandhya, Validated spectrophotometric methods for simultaneous analysis of pyrimethamine and sulfadoxine in pharmaceutical dosage forms. Asian J Pharm Clin Res, 2013. 6 (Suppl 3): p. 121-3.
6. Mohamed, H.M., et al., A UV-Spectrophotometric Chemometric Method for the Simultaneous Determination of Sulfadoxine and Pyrimethamine in Tablets. Asian Journal of Pharmaceutical Research and Health Care. 2016. 8(3): p. 76-83.
7. Fernández, D.M.M., et al., Validation of a liquid chromatographic method for determination of sulphadoxine and pyrimethamine in whole blood spotted on filter paper. Revista Cubana de Farmacia 2012. 46(3): p. 311-319.
8. Kumar, V.A., et al., Stability Indicating RP-HPLC method for the simultaneous estimation of pyrimethamine and sulphadoxine in bulk and tablet dosage form. Journal of Applied Pharmaceutical Science, 2016. 6(03): p. 71-76.
9. Rajapandi, R., et al., Development and validation of RP-HPLC method for the simultaneous estimation of sulfadoxine and trimethoprim in bulk and pharmaceutical dosage forms. Der Pharmacia Lettre, 2016. 8(19): p. 316-323.
10. Arayne, M.S., et al., Simultaneous determination of pyrimethamine, sulfadoxine, mefloquine, and ibuprofen in pharmaceutical formulations by RP-HPLC. Medicinal Chemistry Research, 2010. 19(9): p. 1043-1054.
11. Acheampong, A., et al., Development and validation of RP-HPLC method for simultaneous estimation of sulfadoxine and pyrimethamine in tablet dosage form using diclofenac as internal standard. Cogent Chemistry, 2018. 4(1): p. 389-399.
12. Meena, S. and S. Sandhya, Validated HPTLC method for simultaneous analysis of pyrimethamine and sulphadoxine in pharmaceutical dosage forms. Journal of Chemistry, 2012. 2013: p. 6 pages.
13. Begum, M., et al., Sensitive and Selective Spectrophotometric Methods for the Determination of Cisaprid, Metoclopramide Hydrochloride, Sulphadoxine and Sulphamethoxazole. International Journal of Chemical, Material and Environmental Research, 2016. 3(4): p. 84-90.
14. Divya, K., B. Narayana, and S. Samshuddin, New spectrophotometric methods for the determination of sulfadoxine by the formation of Co (II) complexes. Journal of Saudi Chemical Society, 2016. 20: p. S536-S540.
15. Mohamed, M.H., S.W. Shantier, and E.A. Gadkariem, spectrophotometric methods for the simultaneous determination of sulphadoxine and pyrimethamine in bulk and tablets forms International Journal of Pharmaceutical Research and Bio-Science, 2017. 6(6): p. 16-28.
16. Sharma, S., et al., Spectrophotometric estimation of sulfadoxine in pharmaceutical preparations. Journal of Chemistry, 2010. 7(4): p. 1246-1253.
17. Adegoke, O.A., et al., Simultaneous spectrophotometric determination of trimethoprim and sulphamethoxazole following charge-transfer complexation with chloranilic acid. Arabian Journal of Chemistry, 2017. 10: p. S3848-S3860.
18. Qureshi, S., et al., Spectrophotometric determination of trimethoprim by oxidation in drug formulations. Fresenius' Journal of Analytical Chemistry, 1997. 357(7): p. 1005-1007.
19. Raauf, A.M., H.M. Ali, and H. Hameid, Spectrophotometric Determination of Trimethoprim in Pure Form and Pharmaceutical Formulations with Metol and potassium hexacyanoferrate (ΙΙΙ). Tikret Journal of Pharmaceutical Sciences, 2012. 8(2): p. 217-228.
20. Swetha, G., K.P. Kumar, and K. Sirisha, new validated method for the estimation of sulfamethoxazole and trimethoprim in bulk form by visible spectroscopy. International Journal of Pharmacy and Pharmaceutical Sciences, 2018. 10(12): p. 50-57.
21. Hişmioğulları, Ş. Ege, and E. Yarsan, Spectrophotometric determination and stability studies of sulfamethoxazole and trimethoprim in oral suspension by classical least square calibration method. Hacettepe University Journal of the Faculty of Pharmacy. 2009. 29: p. 95-104.
22. Azeez, M.D., et al., Simultaneous determination of sulfamethaxazole and trimethoprim by using UV-visible spectrophotometer. International Journal of Pharmaceutical Sciences Review and Research, 2013. 23(2): p. 224-227.
23. Balyejjusa, S., R. Adome, and D. Musoke, Spectrophotometric determination of sulphamethoxazole and trimethoprim (co-trimoxazole) in binary mixtures and in tablets. African Health Sciences, 2002. 2(2): p. 56-62.
24. Pokala, R.V., K. Kumari, and H.B. Bollikola, UV spectrophotometry method development and validation of sulfasiazine and triethoprim in combined dosage form. International Journal of Pharmacy and Pharmaceutical Sciences, 2018. 10(1): p. 103-107.
25. Épshtein, N.A., Simultaneous HPLC Determination of Trimethoprim, Sulfamethoxazole, and Methyl- and Propylparaben in Suspensions of the Co-Trimoxazole Type. Pharmaceutical Chemistry Journal, 2002. 36(12): p. 675-679.
26. Giegold, S., et al., Determination of sulfonamides and trimethoprim using high temperature HPLC with simultaneous temperature and solvent gradient. Journal of Separation Science, 2008. 31(20): p. 3497-3502.
27. Goulas, V., et al., A rapid HPLC method for the determination of sulphonamides and trimethoprim in feed premixes. Journal of Animal and Feed Science, 2014. 23(2): p. 185-189.
28. Sayar, E., et al., Development and validation of an HPLC method for simultaneous determination of trimethoprim and sulfamethoxazole in human plasma. European Journal of Drug Metabolism and Pharmacokinetics. 2010. 35(1-2): p. 41-46.
29. Oza, C., et al., Dual Wavelength Spectrophotometric method for the simultaneous determination of Paracetamol and Nabumetone in API and in tablet dosage form. Asian Journal of Pharmaceutical Analysis, 2012. 2(4): p. 122-127.
30. Shibata, S., M. Furukawa, and K. Goto, Dual-wavelength spectrophotometry. General method. Analytica Chemica Acta, 1969. 46: p. 271-279.
31. Chaudhari, S.R., A.S. Patil, and A.A. Shirkhedkar, Studies on derivative spectroscopy and area under curve UV-spectrophotometric methods for estimation of Apremilast in bulk and in-house Tablets. Asian Journal of Pharmaceutical Research, 2018. 8(1): p. 11-16.
32. An, D.T.T. and V.D. Hoang, Simultaneous determination of paracetamol and codeine phosphate in combined tablets by first-order derivative and ratio spectra first-order derivative UV spectrophotometry. Asian Journal of Research in Chemistry. 2009. 2(2): p. 143-147.
33. Balap, R.A., et al., Development and Validation of Spectrophotometric Methods for Estimation of Granisetron Hydrochloride in Pure and it’s Pharmaceutical Dosage Forms. Asian Journal of Research in Chemistry
2010. 3(4): p. 928-931.
34. Reddy, G.C., N. Devanna, and K. Chandrasekhar, Sensitive Spectrophotometric Determination of Ruthenium (III) using Diacetyl Monoxime Isonicotinoyl Hydrazone (DMIH). Asian Journal of Research in Chemistry. 2011. 4(6): p. 997-1000.
35. Reddy, G.C., N. Devanna, and K. Chandrasekhar, Sensitive Spectrophotometric Determination of Ruthenium (III) using Diacetyl Monoxime Isonicotinoyl Hydrazone (DMIH). Asian Journal of Research in Chemistry, 2011. 4(6): p. 997-1000.
36. Chodavadia, R.M., et al., First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Nebivolol Hydrochloride and Indapamide in Tablet Dosage Form. Asian Journal of Research in Chemistry, 2012. 5(2): p. 282-285.
37. Botsoglou, N., et al., Rapid determination of amphotericin B in serum and urine by third-order derivative spectrophotometry. Journal of Pharmaceutical Science, 1996. 85: p. 402-406.
38. Bhatia, N.M., et al., Simultaneous spectrophotometric estimation of the amlodipine besylate and hydrochlorothiazide in pharmaceutical preparations and biological samples. Asian Journal of Research in Chemistry. 2009. 2(4): p. 394-397.
39. Lotfy, H.M. and M. Abdel-Monem Hagazy, Comparative study of novel spectrophotometric methods manipulating ratio spectra: An application on pharmaceutical ternary mixture of omeprazole, tinidazole and clarithromycin. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 2012. 96: p. 259-270.
40. Patel, P.R., V.B. Patel, and M. Bapna, Simultaneous Determination of Levofloxacin and Ornidazole by Ratiospectra Derivative Spectrophotometry and High-Performance Liquid Chromatography. Asian Journal of Research in Chemistry, 2010. 3(4): p. 922-927.
41. Ingale, S.S., et al., Spectrophotometric Simultaneous Determination of Drotaverine Hydrochloride and Diclofenac Potassium in Combined Tablet Dosage Form by Ratio Derivative and Area Under Curve method. Asian Journal of Research in Chemistry, 2011. 4(1): p. 35-39.
42. Branch, S.K.J. J.o.p. and b. analysis, Guidelines from the International Conference on Harmonisation (ICH). 2005. 38(5): p. 798-805.