NEW VALIDATED METHOD DEVELOPMENT FOR THE ESTIMATION OF SULFAMETHOXAZOLE AND TRIMETHOPRIM IN BULK FORM BY VISIBLE SPECTROSCOPY
Objective: To develop three novel, sensitive, simple validated visible spectrophotometric methods for the quantitative estimation of sulfamethoxazole (SMZ) and trimethoprim (TMP) in bulk form.
Methods: Methods were based on coupling the diazotized aromatic primary amino group of the studied drugs with o-phenylenediamine (OPD) in an acidic medium. The first two methods have been proposed for estimation of SMZ and rest for TMP. The resulting products were measured by spectrophotometric (method I, II and III) tools. The methods were validated as per ICH guidelines.
Results: In method I, the absorbance was measured at 482 and 457 nm with linearity ranges of 4.0-40.0 and 5.0-45.0 µg/ml for SMZ. On the other hand, method III was devoted to estimate TMP spectrophotometrically at 457 nm with linearity range of 5-30 μg/ml. The r2 value for all methods were found to be 0.99. The percentage recoveries of SMZ and TMP were found to be 97.98%, 97.56% and 97.55% respectively. The developed methods were subjected to detailed validation procedure in their pure forms.
Conclusion: The study concludes that visible spectrophotometric validation methods can be very efficient and economically promising technique for the quantitative analysis of SMZ and TMP in bulk form. The statistical analysis of data indicates that the developed methods were reproducible and specific. It was found that there is a good agreement between the obtained results and those obtained by the reported methods; moreover they can be used for the routine estimations of SMZ and TMP in bulk form.
2. Taylor RB, Richards RME, Xing DK. Determination of antibacterial agents in microbiological cultures by high-performance liquid chromatography. Analyst 1990;115:797-9.
3. Takagishi Y, Ohsuga K, Ohama S. Suppository containing sulfamethoxazole/trimethoprim complex and process for preparing the same. U. S. Patent US4461765; 1975.
4. Brogden RN, Carmine AA, Heel RC, Speight TM, Avery GS. Trimethoprim: a review of its antibacterial activity, pharmacokinetics and therapeutic use in urinary tract infections. Drugs 1982;23:405–30.
5. Olajire AA, Chinedum PB, Olayinka AK, Oyakhire O. Simultaneous spectrophotometric determination of trimethoprim and sulphamethoxazole following charge-transfer complexation with chloranilic acid. Arabian J Chem 2017;10:S3848-60.
6. Goran S, Elizabeta DS, Marija S, Romel V. Optimization, validation and application of UV-visible spectrophotometric-colorimetric methods for determination of trimethoprim in different medicinal products. Maced Vet Rev 2016;39:65-76.
7. Santosh J, Pradip D, Ajit G, Laxmi J. Simultaneous estimation of trimethoprim and sulfamethoxazole in combined dosage form by UV-spectrophotometric methods. Asian J Pharm Technol Innovation 2015;3:54-62.
8. Zaman SM. Analytical method development for the spectrophotometric determination of sulfamethoxazole in bulk drug and pharmaceutical preparation. J Chem Biochem 2015;3:63-74.
9. Azeez MD, Kiran KB, Manoranjan, Venkateshwarlu G, Manindar B, Naresh Y. Simultaneous determination of sulfamethoxazole and trimethoprim by using a UV-visible spectrophotometer. Int J Pharm Sci Rev Res 2013;23:224-7.
10. Medina JR, Miranda M, Hurtado M, Adriana MD, Ruiz-Segura JC. Simultaneous determination of trimethoprim and sulfamethoxazole in immediate-release oral dosage forms by first-order derivative spectroscopy: application to dissolution studies. Int J Pharm Pharm Sci 2013;5:505-10.
11. Sangita S, Neog M, Dipti D. Development and validation of spectrophotometric methods for estimating sulfamethoxazole in pharmaceutical preparations. Int J Pharm Sci Drug Res 2010;2:204-9.
12. Padmarajaiah N, Shailendra DN, Ashwinee KS, Shivakumar A. A sensitive spectrophotometric method for the determination of sulfonamides in pharmaceutical preparations. Acta Pharm 2007;57:333–42.
13. Ayad Raauf MR, Huda MA, Halah H. Spectrophotometric determination of trimethoprim in pure form and pharmaceutical formulations with metol and potassium hexacyanoferrate (???). Tikrit J Pharm Sci 2012;8:209-20.
14. Mahmoud RS, Mojgan F, Arezoo HN. Simultaneous spectrophotometric determination of sulfamethoxazole and trimethoprim in pharmaceutical preparations by using multivariate calibration methods. J Appl Chem Res 2010;3:48-52.
15. Pokala RV, Kumari K, Bollikola HB, UV spectrophotometry method development and validation of sulfadiazine and trimethoprim in combined dosage form. Int J Pharm Pharm Sci 2018;10:103-7.
16. Shamsa F, Amani L. Determination of sulfamethoxazole and trimethoprim in pharmaceuticals by visible and UV spectrophotometry. Iran J Pharm Res 2016;1:31-6.
17. Amorim KP, Romualdo LL, Andrade LS. Electrochemical degradation of sulfamethoxazole and trimethoprim at boron-doped diamond electrode: performance, kinetics and reaction pathway. Sep Purif Technol 2013;120:319-27.
18. Srinivasa RJ, Vejendla RK, Ravali N, Varnalatha K, Kalpana K. Rapid UPLC method for simultaneous estimation of sulfamethoxazole and trimethoprim in pharmaceutical dosage forms. Indo Am J Pharm Res 2014;4:896-904.
19. Wang JC, Zhang Q, Cai DF. Stability indicating validated HPLC method for analysis of berberine hydrochloride and trimethoprim in the pharmaceutical dosage form. J Chemistry 2013;1-9. http://dx.doi.org/10.1155/2013/360812
20. Kasim LS, Awoyemi AA, Coker HAB, Adepojubello AA, Aziba PI. Chemical evaluation of sulfamethoxazole in some brands of cotrimoxazole. J Res Opinion 2012;2:66-9.
21. Madhulika CH, Anton Smith A, Seetaramaiah K, Kottai Muthu A, Manavalan R. Spectrofluorometric determination of sulphamethoxazole in a pharmaceutical formulation. Int J Pharm Sci Rev Res 2011;7:198-202.
22. Sabriye P, Ozkorucuklu I, Yucel Sahin II, Guleren AI. Determination of sulfamethoxazole in pharmaceutical formulations by flow injection system/HPLC with potentiometric detection using polypyrrole electrode. J Braz Chem Soc 2011;22:2171-7.
23. Feng, FLY, Zhao C, Tang PLB. Simple colorimetric sensing of trace bleomycin using unmodified gold nanoparticles. Biosens Bioelectron 2011;26:4628-31.
24. Vijayalakshmi R, Sowjanya D, Archana S, Dhanaraju MD. Application of extractive spectrophotometric methods for the determination of flucloxacillin and trandolapril using bromocresol green. Asian J Pharm Clin Res 2014;7:216-8.
25. Ginting N, Silalahi J, Pardede TR, Sudarmi S, Nerdy N. Effect of harvesting time at morning, afternoon, and evening on nitrate and nitrite level in spinach (amaranthus tricolor l.) and mustard (brassica rapa l.). Asian J Pharm Clin Res 2018;11:110-3.
26. Jiao K, Sun W, Zhang S, Sun G. Application of p-phenylenediamine as an electrochemical substrate in a peroxidase-mediated voltammetric enzyme immunoassay. Anal Chim Acta 2000;413:71–8.
27. Vogel’s textbook of quantitative chemical analysis. Mendham J, Denney RC, Barnes JD, Thomas MJK. 6th ed. Singapore: Pearson education ltd; 2000. p. 165.
28. Sharma S, Neog M, Dabhi D. Development and validation of spectrophotometric methods for estimating sulfamethoxazole in pharmaceutical preparations. Int J Pharm Sci Drug Res 2010;2:204-9.
29. Shamsa F, Amani L. Determination of sulfamethoxazole and trimethoprim in pharmaceuticals by visible and uv spectrophotometry. Iran J Pharm Res 2006;1:31-6.
30. Nagaraja P, Sunitha KR, Vasantha RA, Yathirajan HS. Iminodibenzyl as a novel coupling agent for the spectrophotometric determination of sulfonamide derivatives. Eur J Pharm Biopharm 2002;53:187-92.
31. International Conference of Harmonization. Validation of analytical procedures: Text and methodology. Geneva, Switzerland: ICH Q2 [R1]; 2005.
32. Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry, Prentice Hall/Pearson, Harlow, England; 2010.
33. Ramadan AA, Mandil H, Dahhan M. Spectrophotometric determination of cefixime in pure form and in syrian pharmaceuticals through complexation with Cu (II). Asian J Chem 2013;25:3457-62.
34. British Pharmacopoeia. Vol. I. Her Majesty's Stationary Office, Published by the British Pharmacopoeia Commission; London: 1998. p. 1620, 1952.
35. United States Pharmacopoeia XXIV, USP Convention, Inc. Rockville: MD 20852; 2000. p. 496, 1560.