Validated chromatographic methods for the simultaneous determination of a ternary mixture of sulfacetamide sodium and two of its official impurities; sulfanilamide and dapsone

• Autorzy: El-Ragehy Nariman A. , Hegazy Maha A. , Tawfik Samia A. , Sedik Ghada A.

Identyfikatory

DOI

10.1556/1326.2021.00921

• Języki publikacji: EN

Abstrakty

EN

Sulfacetamide sodium is a widely prescribed sulfonamide drug due to its topical antibacterial action on eye and skin. Four impurities are stated in the British Pharmacopoeia among which are sulfanilamide and dapsone. This work presents two specific, accurate and precise chromatographic methods for the simultaneous determination of a mixture of sulfacetamide sodium, sulfanilamide and dapsone. The first method is an isocratic RP-HPLC where the separation of components was achieved on C18 column. A green mobile phase was used consisting of methanol:water (60:40, v/v). The flow rate was 1.0 mL/min and effluent was monitored at 273 nm. The second method is a TLC-spectrodensitometric one where good separation was achieved by using silica plates and a mobile phase consisting of chloroform:dichloromethane:acetic acid (6:2.5:1.5, by volume). Determination was done by densitometry in the absorbance mode at 273 nm. Both methods were validated in compliance with ICH guidelines. They were also successfully applied for the determination of sulfacetamide sodium and its impurities in Ocusol® ophthalmic solutions. The obtained results were statistically compared to the results obtained by applying the official methods of analysis of each component where no significant difference was found with respect to accuracy and precision.

Słowa kluczowe

EN

dapsone; HPLC; sulfacetamide sodium; sulfanilamide; TLC- spectrodensitometry

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2022
• Tom: Vol. 34, no. 4
• Strony: 377--385
• Opis fizyczny: Bibliogr. 24 poz., rys., tab., wykr.

Twórcy

autor

El-Ragehy Nariman A.

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

autor

Hegazy Maha A.

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

autor

Tawfik Samia A.

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

• https://orcid.org/0000-0003-2145-4696

autor

Sedik Ghada A.

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

Bibliografia

• 1. Rahman, N.; Azmi, S.N.H.; Wu, H.F. The importance of impurity analysis in pharmaceutical products: an integrated approach. Accreditation Qual. Assur. 2006, 11, 69–74.
• 2. Bari, S.B.; Kadam, B.R.; Jaiswal, Y.S.; Shirkhedkar, A.A. Impurity profile: significance in active pharmaceutical ingredient. Eurasian J. Anal. Chem. 2007, 2, 32–53.
• 3. The British Pharmacopoeia. The Stationary Office; London, 2016.
• 4. Brunton, L.; Chabner, B.; Knollman, B. Goodman & Gilman’s the Pharmacological Basis of Therapeutics. 12th ed.; The McGraw-Hill Companies: New York, 2011.
• 5. Agarwal, R. Textbook on Clinical Ocular Pharmacology & Therapeutics; JP Medical Ltd, 2014.
• 6. Sweetman, S.C. Martindale the Complete Drug Reference; The Pharmaceutical Press: London, 2011.
• 7. Zhang, K.; Ma, P.; Jing,W.; Zhang, X. A developed HPLC method for the determination of Alogliptin Benzoate and its potential impurities in bulk drug and tablets. Asian J. Pharm. Sci. 2015, 10, 152–8.
• 8. Ragab, M.A.; Eman, I. High performance liquid chromatography with photo diode array for separation and analysis of naproxen and esomeprazole in presence of their chiral impurities: enantiomeric purity determination in tablets. J. Chromatogr. A 2017, 1497, 110–7.
• 9. Al Alamein, A.M.A.; Saad, A.S.; Galal, M.M.; Zaazaa, H.E. A comparative study of different chromatographic techniques for determination of toxic impurities of some commonly used anesthetics. JPC-Journal of Planar Chromatography-Modern TLC 2018, 31, 280–9.
• 10. Xu, S.; Wu, L. Determination of sulfacetamide sodium and sulfanilamide in shao tang ling ointment by high performance liquid chromatography. Chin. J. Chromatogr. 1999, 17, 206–7.
• 11. Guo, X.G.; Guo, X.J.; Guo, H.B. Simultaneous determination of sulfacetamide sodium and impurity sulfanilamide in sulfacetamide sodium eye drops by HPLC. China Pharm. 2013, 25.
• 12. Gruber, M.P.; Klein, R.W. TLC determination of sulfanilamide as a degradation product in pharmaceutical preparations containing sodium sulfacetamide. J. Pharm. Sci. 1968, 57, 1212–4.
• 13. Penner, M.H. Assay of sulfacetamide sodium ophthalmic solutions by high-pressure liquid chromatography. J. Pharm. Sci. 1975, 64, 1017–9.
• 14. Hall, L.; Chadwick, V. Quantitative determination of sulfanilamide in sodium sulfacetamide raw material and ophthalmic solutions by high-performance liquid chromatography. J. Chromatogr. A 1989, 478, 438–45.
• 15. The United States Pharmacopeia and National Formulary; USP 34-NF 29; U.S. Pharmacopeial Convention: Rockville, USA, 2011.
• 16. Seshachalam, U.; Haribabu, B.; Chandrasekhar, K.B. Development and validation of a stability-indicating liquid chromatographic method for determination of emtricitabine and related impurities in drug substance. J. Separat. Sci. 2007, 30, 999–1004.
• 17. Nageswara Rao, R.; Narasa Raju, A. Simultaneous separation and determination of process-related substances and degradation products of venlafaxine by reversed-phase HPLC. J. Separat. Sci. 2006, 29, 2733–44.
• 18. Rao, R.N.; Nagaraju, V. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs. J. Pharm. Biomed. Anal. 2003, 33, 335–77.
• 19. Sherma, J.; Fried, B. Hand Book of Thin-Layer Chromatography, 2nd ed.; Mercel Dekker: New York, 2003.
• 20. Capello, C.; Fischer, U.; Hungerbuhler, K. What is a green solvent? A comprehensive framework for the environmental assessment of solvents. Green. Chem. 2007, 9, 927–34.
• 21. Weston, A.; Brown, P.R. HPLC and CE; Principles and Practice; Academic Press: USA, 1997.
• 22. Variyar, P.S.; Chatterjee, S.; Sharma, A. High-performance thinlayer chromatography (HPTLC), Chapter 2: Fundmentals and Theory of HPTLC-Based Separation, Springer: New York, 2011.
• 23. International Conerence on Harmonaization, Q2(R1), Validation of Analytical Procdures: Text and Methodology; Geneva, Switzerland, 2005.
• 24. Spiegel, M.; Stephens, L. Schaum’s Outline of Theory and Problems of Statistics; The McGraw-Hill Companies: New York, 1999.

Uwagi

Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).