Development and Validation of RP-HPLC Method for Quantitative Analysis of Sulfamethoxazole and Trimethoprim in Liquid Suspension: A Comparative Study with Compendial Method
Abstract
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Co-trimoxazole is a combination of trimethoprim or sulfamethoxazole. It is used to treat common infectious diseases, including the lung disorders, urinary disorders, and gastrointestinal infections. The current study was performed to develop a new RP-HPLC technique. The main purpose was to analyze SMX (Sulfamethoxazole) and TMP (Trimethoprim) in a liquid medium of 60mL. The analyses of SMX and TMP were performed on RP-HPLC with a C18 column (25 cm × 4.6 mm) packed with 5 µm ODS, L1 stationary phase, while the mobile phase consisted of methanol and water with a ratio of 6:4. The pH of the system was adjusted to 2.6 by using dilute phosphoric acid. The injection volume was 20μL having a flow rate of 1 mL/minute and column temperature of 40ºC. The analysis of all chromatograms was performed at a single wavelength of 254 nm. The validation of the method was determined for range, precision, linearity, specificity, accuracy, and system suitability. This method was found to be more environmentally friendly with respect to the other compendial methods, which are used for the TMP and SMX analysis.
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References
Akay C, Özkan SA. Simultaneous LC determination of trimethoprim and sulphamethoxazole in pharmaceutical formulations. J Pharm Biomed Anal. 2002;30(4):1207–1213. https://doi.org/10.1016/s0731-7085(02)00460-0
Al-Saidi KH, Yonis MS. Simultaneous determination of sulphamethoxazole and trimethoprim in binary mixtures and in tablet using derivative spectrophotometry. J Al-Nahrain Uni. 2018;18(1):46–54.
Cribb AE, Spielberg SP. Sulfamethoxazole is metabolized to the hydroxylamine in humans. Clin Pharm Therap. 1992;51(5):522–526. https://doi.org/10.1038/clpt.1992.57
Dantas RF, Contreras S, Sans C, Esplugas S. Sulfamethoxazole abatement by means of ozonation. J Hazard Mater. 2008;150(3):790–794. https://doi.org/10.1016/j.jhazmat.2007.05.034
Roedel MM, Nakada SY, Penniston KL. Sulfamethoxazole-induced sulfamethoxazole urolithiasis: a case report. BMC Urol. 2021;21(133):1–5. https://doi.org/10.1186/s12894-021-00894-5
Shewiyo DH, Kaale E, Risha PG, Dejaegher B, Smeyers–Verbeke J, Vander-Heyden, Y. Development and validation of a normal-phase high-performance thin layer chromatographic method for the analysis of sulfamethoxazole and trimethoprim in co-trimoxazole tablets. J Chromatogr A. 2009:1216(42):7102–7107. https://doi.org/10.1016/j.chroma.2009.08.076
Abass AM, Alabdullah S, Salman, HG. Determination of trimethoprim by various analytical techniques- A – review. Int J Res Eng Inno. 2020;4(1):1–4. http://doi.org/10.36037/IJREI.2020.4101
Gonzalez D, Melloni C, Poindexter BB, et al. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis. 2015;7(9):1137–1149. https://doi.org/10.4155/bio.15.38
Rajith L, Kumar KG. Electroanalysis of trimethoprim on metalloporphyrin incorporated glassy carbon electrode. Drug Test Anal. 2010;2(9):436–441. https://doi.org/10.1002/dta.161
Bushby SRM, Hitchings GH. Trimethoprim, a sulphonamide potentiator. Br J Pharmacol Chemothera. 1968;33(1):72–90. https://doi.org/10.1111/j.1476-5381.1968.tb00475.x
Gurumurthy T, Monika M, Ashwini V. Development and validation RP-HPLC method for simultaneous estimation of Sulfamethoxazole and Trimethoprim. Ind J Biotech Pharm Res. 2017;5(3):235–238.
Abrahem SA, Abass AM, Ahmed A. Trimethoprim determination with drug-selective electrodes. Asian J Pharm Clin Res. 2019;12(6):83–87.
Darrell JH, Garrod LP, Waterworth PM. Trimethoprim: laboratory and clinical studies. J Clin Pathol. 1968;21(2):202–209. https://doi.org/10.1136/jcp.21.2.202
Yao J, Shi YQ, Li ZR, Jin SH. Development of a RP-HPLC method for screening potentially counterfeit anti-diabetic drugs. J Chromatogr B. 2007;853(1-2):254–259. https://doi.org/10.1016/j.jchromb.2007.03.022
Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK. A new improved RP-HPLC method for assay of rosuvastatin calcium in tablets Ind J Pharm Sci. 2010;72(5):592–598. https://doi.org/10.4103/0250-474X.78526
Yabré M, Ferey L, Somé IT, Gaudin K. Greening reversed-phase liquid chromatography methods using alternative solvents for pharmaceutical analysis. Molecules. 2018;23(5):1–25. https://doi.org/10.3390/molecules23051065
Braun AC, Ilko D, Merget B, et al. Predicting critical micelle concentration and micelle molecular weight of polysorbate 80 using compendial methods. Eur J Pharm Biopharm. 2015;94:559–568. https://doi.org/10.1016/j.ejpb.2014.12.015
Speer I, Preis M, Breitkreutz J. Dissolution testing of oral film preparations: Experimental comparison of compendial and non-compendial methods. Int J Pharm. 2019;561:124–134. https://doi.org/10.1016/j.ijpharm.2019.02.042
Van den Bossche L, Lodi A, Schaar J, et al. An interlaboratory study on the suitability of a gradient LC-UV method as a compendial method for the determination of erythromycin and its related substances. J Pharm Biomed Anal. 2010;53(1):109–112. https://doi.org/10.1016/j.jpba.2010.03.012
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