OPEN ACCESS | PEER-REVIEWED | RESEARCH ARTICLE | DOWNLOAD PDF | VIEW FULL-TEXT PDF | TOTAL VIEWS
Purity assessment and determination of sertaconazole in bulk and pharmaceutical formulations based on spectrophotometric and chromatographic approaches
Amal Mahmoud Abou Al Alamein (1,*)
(1) Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, 11562, Cairo, Egypt
(*) Corresponding Author
Received: 28 Jun 2015 | Accepted: 26 Jul 2015 | Published: 31 Dec 2015 | Issue Date: December 2015
Stability evaluation of the drug substance is an integral part of the systematic approach to stability studies. Hence, three simple, sensitive and precise methods depending on two different techniques as UV spectrophotometry and chromatography were adopted for the task of stability indicating determination of sertaconazole (SER) in presence of its acidic degradation products. The first method is Zero-crossing first derivative (1D) spectrophotometric one, which allows the determination of SER over a concentration range of 4-64 µg/mL at 290 nm with mean percentage recoveries 99.77±0.781. While first-derivative of the ratio spectra (1DR) is the method of choice for determination of pure SER at a maximum 300 nm and at a trough 304 nm, with mean percentage recoveries 99.98±0.720 and 100.46±0.640, respectively. The third developed HPLC method used a RP-ZORBAX C18 column (5 μm particle size, 250×4.6 mm; id) with isocratic elution. The mobile phase was methanol: 0.2% formic acid aqueous solution (75:25, v:v); pH = 3.5 at the flow rate of 1.0 mL/min, with UV detection at 260 nm. The method could determine SER in the range of 0.8-40 µg/mL with a mean percentage recovery of 99.65±0.630. The developed methods were succeeded in the determination of SER in bulk powder, pharmaceutical dosage forms and in presence of its acidic degradation products. The results obtained were validated in compliance with ICH guidelines and compared statistically with each other and to those of the official method in the British Pharmacopoeia regarding both accuracy and precision.
Links for Article
| | | | | | |
| | | | | | |
| | | |
Article MetricsThis Abstract was viewed 943 times | PDF Article downloaded 496 times
. Maha Osama El-Kayal, Maha Nasr Sayed, Nahed Dawood Mortada, Seham Elkheshen
Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations
European Journal of Chemistry 9(1), 7, 2018
. Sandeep Sonawane, Santosh Chhajed, Meghana Amale, Moreshwar Patil, Pallavi Bhagade, Alpana Bastikar, Sanjay Kshirsagar
Development and Validation of Stability-Indicating HPLC Method for Estimation of Sertaconazole Nitrate in Bulk and Topical Formulation: Application to Chemical Kinetics, Characterization and in silico Toxicity Prediction of its Acid Degradation Product
Analytical Chemistry Letters 9(1), 86, 2019
. Mostafa M. Baker, Dina Salah El-Kafrawy, Magdi M. Abdel-Khalek, Tarek S. Belal
A Highly Selective Stability-Indicating HPLC Method for Simultaneous Estimation of Sertaconazole with Two Coformulated Preservatives in Pharmaceutical Dosage Forms
Chromatographia 83(2), 191, 2020
. Sweetman, S. Martindale: The Complete Drug Reference, 36th Edition, The Pharmaceutical Press, London, 2009.
. Palacin, C.; Tarrago, C.; Ortiz, J. A. Int. J. Gynecol. Obstet. 2000, 71, 37-46.
. Ghannoum, M. A.; Rice, L. B. Clinical Microbiol. Rev. 1999, 12, 501-517.
. British Pharmacopoeia Commission, British pharmacopoeia, London, England, Stationery Office, 2014.
. European Pharmacopeia Commission, 5th Edition, Supplement 5.2, Council of Europe, Strasbourg, 2005.
. Dehghan, M. H. G.; Shahed, M.; Satapathy, A. A.; Ahamad, W. Pharm. Anal. Qual. Assur. 2011, 3, 141-143.
. Salama, N.; Mohamed, A. Bull. Chem. Soc. Ethiopia 2009, 23, 167-174.
. Albet, C.; Fernandez, J.; Rozman, E.; Perez, J.; Sacristan, A.; Ortiz, J. J. Pharm. Biomed. Anal. 1992, 10, 205-211.
. Yuanyuan, W.; Lulu, P.; Manying, W.; Ning, O. A. J. Chromatogr. B 2009, 877, 4047-4050.
. Rizk, M.; Toubar, S.; El-Alamin, M.; Azab, M. Bull. Fac. Pharm. Cairo Univ. 2014, 52(1), 155-164.
. Nemutlu, E.; Yardimci, C.; Ozaltin, N. Anal. Chim. Acta 2005, 547, 83-88.
. Antonio, A.; Gianni, P.; Samuele, R.; Sergio, S. J. Chem. Soc. Perkin Trans. 2001, 2, 296-301.
. Robin, A. C. Advances in Physical Organic Chemistry, 1st Edition, Academic Press, London, 2012.
. Hussien, L. A. A.; Ghani, M. F. A.; El-Alamein, A. M. A.; Mohamed, E. H. Eur. J. Chem. 2014, 5, 311‐320.
. The United States Pharmacopeia (USP33), National Formulary (NF 28). Rockville: The United States Pharmacopeial Convention, Inc. 2010.
. Andrea, W.; Phyllis, R. HPLC and CE, principles and practice, Academic Press, London 1997.
. Miller, J. C.; Miller, J. N. Statistics and Chemometrics for Analytical Chemistry, 5th Edition, Harlow, England, Pearson Education Limited, 2005, pp. 39-73, 107-149, 256.
. International conference on harmonization (ICH), Validation of Analytical Procedures: Text and Methodology, 2008.
. Spiegel, M. R.; Stephens, L. J. Schaum' Outline of Theory and Problems of Statistics, Schaum' Outline Series, New York, 1999.
How to cite
The other citation formats (EndNote | Reference Manager | ProCite | BibTeX | RefWorks) for this article can be found online at: How to cite item
DOI Link: https://doi.org/10.5155/eurjchem.6.4.381-386.1296
| | | | | | | | |
| | | | | | |
Save to Zotero Save to Mendeley
European Journal of Chemistry 2015, 6(4), 381-386 | doi: https://doi.org/10.5155/eurjchem.6.4.381-386.1296 | Get rights and content
- There are currently no refbacks.
© Copyright 2010 - 2021 • Atlanta Publishing House LLC • All Right Reserved.
The opinions expressed in all articles published in European Journal of Chemistry are those of the specific author(s), and do not necessarily reflect the views of Atlanta Publishing House LLC, or European Journal of Chemistry, or any of its employees.
Copyright 2010-2021 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 2850 Smith Ridge Trce Peachtree Cor GA 30071-2636, USA. Registered in USA.