SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF ETHAMSYLATE IN THE PRESENCE OF ITS DEGRADATION PRODUCT HYDROQUINONE
Abstract
Ethamsylate was determined in the presence of its known degradation product, hydroquinone, as an impurity using spectrophotometric methods. Four spectrophotometric methods; second derivative, derivative ratio, ratio difference, and dual wavelength, were evaluated. The accuracy, precision, and linear range were determined for each method, and the methods were validated as per ICH guidelines. The specificity of each method was assessed by analyzing synthetic mixtures containing different proportions of the degradation product and drug. The developed methods were applied to the determination of ethamsylate in bulk powder and two dosage forms.
About the Authors
Hany Hunter Monir
Cairo University
Egypt
Analytical Chemistry Department, Faculty of Pharmacy, 11562 Cairo
Egypt
Analytical Chemistry Department, Faculty of Pharmacy, 11562 Cairo
Heba Abdelrehim Mohamed
Pharmaceutical Patent Examiner, Egyptian Patent Office, Academy of Scientific Research and Technology
Egypt
11516 Cairo
Egypt
11516 Cairo
Amr M. Badawy
Future University in Egypt
Egypt
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, 12311 Cairo
Egypt
Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, 12311 Cairo
Marianne Nebsen Morkos
Cairo University
Egypt
Analytical Chemistry Department, Faculty of Pharmacy, 11562 Cairo
Egypt
Analytical Chemistry Department, Faculty of Pharmacy, 11562 Cairo
References
1. S. C. Sweetman, in: Martindale: The Complete Drug Reference, 36 th edn., The Pharmaceutical Press, London, 1064–2272 (2009).
2. N. El-Enany, F. Belal, M. Rizk. J. AOAC Int., 90, 679–685 (2007).
3. Y. El-Shabrawy, N. El-Enany, K. Salem, Farmaco, 59, 803–808 (2004).
4. F. Belal, A. El-Brashy, N. El-Enany, M. Tolba, J. Fluoresc., 21, 1371–1384 (2011).
5. Y. S. Jaiswal, G. S. Talele, S. J. Surana, J. Planar Chromatogr., 106, 460–464 (2005).
6. Y. S. Jaiswal, G. S. Talele, S. J. Surana, J. Planar Chromatogr., 105, 380–383 (2005).
7. S. F. Wang, Q. Xu, Bioelectrochemistry, 70, 296–300 (2007).
8. Z. H. Wang, D. Zhang, Y. Zhang, S. P. Zhou, Fenxi Huaxue, 9, 83–86 (2001).
9. F. Z. Yang, C. Zhang, W. R. G. Baeyens, X. R. Zhang, J. Pharm. Biomed. Anal., 30, 473–478 (2002).
10. J. X. Du, Y. H. Li, Y. Tang, J. R. Lu, Anal. Lett. 35, 463–472 (2002).
11. J. Li, H. Ju, Electrophoresis, 27, 3467–3474 (2006).
12. H. Sun, L. Wei, Y. Wu, N. Liu, J. Chromatogr. B, 878, 1899–1903 (2010).
13. The British Pharmacopoeia (electronic version). Her Majesty’s Stationary Office, London (2012).
14. N. Kaul, H. Agrawal, A. Kakad, S. R. Dhaneshwar, B. Patil, Anal. Chim. Acta, 536, 49–70 (2005).
15. Sigma-Aldrich Catalogue. http://www.sigmaaldrich.com/catalog/DisplayMSDSContent.do (accessed 24 April 2016).
16. F. Salinas, J. J. Nevado, A. E. Mansilla, Talanta, 37, 347–351 (1990).
17. E. S. Elzanfaly, A. S. Saad, A. B. Abd-Elaleem, Saudi Pharm. J., 20, 249–253 (2012).
18. H. M. Lotfy, M. A. Hegazy, Spectrochimica Acta A: Mol. Biomol. Spectrosc., 113, 107–114 (2013).
19. International Conference on Harmonization, Validation of Analytical Procedures: Text and Methodology Q2 (R1), current step 4 version (2005).
20. M. Spiegel, L. Stephens, Schaum’s Outline of Theory and Problems of Statistics, The McGraw-Hill Companies, New York (1999).
Review
For citations:
Monir H.H., Mohamed H.A., Badawy A.M., Morkos M.N. SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF ETHAMSYLATE IN THE PRESENCE OF ITS DEGRADATION PRODUCT HYDROQUINONE. Zhurnal Prikladnoii Spektroskopii. 2019;86(3):388-393.
Views: 296
Email this article 