Email this article 
Hide
Show all
OPEN ACCESS | 
PEER-REVIEWED |
RESEARCH ARTICLE
|
DOWNLOAD PDF
|
VIEW FULL-TEXT PDF
| TOTAL VIEWS
A validated stability indicating HPLC method for determination of sitagliptin
Ola Ahmed Saleh (1)
, Aida Abd El-Sattar El-Azzouny (2) , Hassan Youssef Aboul-Enein (3,*) , Amr Mohamed Badawey (4) (1) Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Centre, 12311 Dokki, Cairo, Egypt
(2) Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Centre, 12311 Dokki, Cairo, Egypt
(3) Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Division, National Research Centre, 12311 Dokki, Cairo, Egypt
(4) Pharmaceutical Chemistry Department, Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University, 12311, Cairo, Egypt
(*) Corresponding Author
Received: 22 Apr 2014 | Revised: 21 May 2014 | Accepted: 21 May 2014 | Published: 30 Sep 2014 | Issue Date: September 2014
Abstract
A comparative and stability-indicating reversed phase high performance liquid chromatographic study have been developed and validated for sitagliptin phosphate. The liquid chromatographic determination was achieved isocratically on Poroshell 120 EC-C18 (100 × 4.6 mm, i.d.; particle size, 2.7 µm), Pursuit 5PFP (150 × 4.6 mm, i.d.; particle size, 5 µm) and Chromolith performance RP-18e (100 × 4.6 mm, i.d.; macropore diameter, 2 µm) columns using a mobile phase consisting of methanol:water:triethylamine:acetic acid (60:40:0.1:0.1; v:v:v:v), at a flow rate 0.5 mL/min and UV detection at 268 nm. The method was linear over the concentration range of 100-1000 µg/mL (r = 0.9998) with a limit of detection and quantitation of 10 and 30 µg/mL, respectively. All the validation parameters and stability indicating study were studied on Poroshell 120 EC-C18 column, which achieved the best separation. The proposed method has been found to have the required accuracy, selectivity, sensitivity, and precision to assay sitagliptin phosphate in bulk form and in a pharmaceutical dosage form. Degradation products resulting from the stress studies did not interfere with the detection of sitagliptin phosphate that indicates that the assay are stability-indicating assay.
Announcements
Our editors have decided to support scientists to publish their manuscripts in European Journal of Chemistry without any financial constraints.
1- The article processing fee will not be charged from the articles containing the single-crystal structure characterization or a DFT study between September 15, 2023 and October 31, 2023 (Voucher code: FALL2023).
2. A 50% discount will be applied to the article processing fee for submissions made between September 15, 2023 and October 31, 2023 by authors who have at least one publication in the European Journal of Chemistry (Voucher code: AUTHOR-3-2023).
3. Young writers will not be charged for the article processing fee between September 15, 2023 and October 31, 2023 (Voucher code: YOUNG2023).
Editor-in-Chief
European Journal of Chemistry
Keywords
Full Text:
PDF
DOI: 10.5155/eurjchem.5.3.497-502.1080
Links for Article
| | | | | | |
| | | | | | |
| | | |
Related Articles
Article Metrics
This Abstract was viewed 1349 times |
PDF Article downloaded 700 times
Citations
[1]. Hari Naga Prasada Reddy Chittireddy, J. V. Shanmukha Kumar, Anuradha Bhimireddy, Mohammed Rafi Shaik, Merajuddin Khan, Syed Farooq Adil, Mujeeb Khan, Fatimah N. Aldhuwayhi
Development and Validation for Quantification of 7-Nitroso Impurity in Sitagliptin by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry
Molecules 27(23), 8581, 2022
DOI: 10.3390/molecules27238581
References
[1]. Herman, G. A.; Stevens, C.; Dyck, K. V.; Bergman, A.; Yi, B.; De Smet, M.; Snyder, K.; Hilliard, D.; Tanen, M.; Tanaka, W.; Wang, A. Q.; Zeng, W.; Musson, D.; Winchell, G.; Davis, M. J.; Ramael, S.; Gottesdiener, K. M.; Wagner, J. Clin. Pharmacol. Ther. 2005, 78, 675-688.
http://dx.doi.org/10.1016/j.clpt.2005.09.002
[2]. Amori, R. E.; Lau, J.; Pittas, A. G. JAMA 2007, 298, 194-206.
http://dx.doi.org/10.1001/jama.298.2.194
[3]. Rosenstok, J.; Sankoh, S.; List, J. F. Diabetes Obes. Metab. 2008, 10, 376-386.
http://dx.doi.org/10.1111/j.1463-1326.2008.00876.x
[4]. Herman, G. A.; Bergman, A.; Liu, F.; Stevens, C.; Wang, A. Q.; Zeng, W.; Chen, L.; Snyder, K.; Hilliard, D.; Tanen, M.; Tanaka, W.; Meehan, A. G.; Lasseter, K.; Dilzer, S.; Blum, R.; Wagner, J. A. J. Clin. Pharmacol. 2006, 46, 876-886.
http://dx.doi.org/10.1177/0091270006289850
[5]. Eligar, V. S.; Bain, S. C. Drug Des. Dev. Ther. 2013, 7, 893-903.
[6]. Vincent, S. H.; Reed, J. R.; Bergman, A. J.; Elmore, C. S.; Zhu, B.; Xu, S.; Ebel, D.; Larson, P.; Zeng, W.; Chen, L.; Dilzer, S.; Lasseter, K.; Gottesdiener, K.; Wagner, J. A.; Herman, G. A. Drug Metab. Dispos. 2007, 35, 533-538.
http://dx.doi.org/10.1124/dmd.106.013136
[7]. Wei, Z.; Donald, G. M.; Alison, L. F.; Li, C.; Michael, S. S.; Eric, J. W.; Amy, Q. W. J. Pharmaceut. Biomed. 2008, 46, 534-542.
http://dx.doi.org/10.1016/j.jpba.2007.11.003
[8]. Ramakrishna, N.; Vishwottam, K.; Koteshwara, M.; Prashanth, K.; Raghupathi, A.; Rajeshkumar, B. Biomed. Chromatogr. 2008, 22, 214-222.
http://dx.doi.org/10.1002/bmc.926
[9]. Beconi, M. G.; Reed, J. R.; Teffera, Y.; Xia, Y. Q.; Kochansky, C. J.; Liu, D. Q.; Xu, S.; Elmore, C. S.; Ciccotto, S.; Hora, D. F.; Stearns, R. A.; Vincent, S. H. Drug Metab. Dispos. 2007, 35, 525-532.
http://dx.doi.org/10.1124/dmd.106.013110
[10]. Sekaran, C. B.; Prameela, R. Int. J. Pharm. Pharm. Sci. 2010, 2, 138-142.
[11]. Raja, T.; Rao, A. L. Int. J. Pharm. Chem. Biol. Sci. 2012, 2, 696-702.
[12]. Maste, M. M.; Parate, A. N.; Bhat, A. R. Asian J. Res. Chem. 2011, 4, 1466-1468.
[13]. Lavanya, R.; Yunoos, Md. J. Adv. Pharm. Edu. Res. 2013, 3, 475-479.
[14]. Pathan, H.; Sreenivas, R. T.; Chandanam, S.; Ashok, R.; Swetha, K. DHR Int. Pharm. Sci. 2014, 5, 80-87.
[15]. Moffat, A. C.; Osselten, M. D.; Widdop, B. Clarke's Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids and Post Mortem Material, 3rd Edn., Pharmaceuticals Press: London, 2004.
[16]. Clark, E. G. C. Clarke's Isolation and Identification of Drugs in Pharmaceuticals Body Fluids and post-Mortem Materials, 2nd Edn. The Pharmaceutical Press: London, 1986.
[17]. Hinchen, J. D. Practical Statistics for Chemical Research, 1st Edn. Methuen and Science Paperbacks, London, 1969.
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.5.3.497-502.1080
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
Save to Zotero
Save to Mendeley
European Journal of Chemistry 2014, 5(3), 497-502 | doi: https://doi.org/10.5155/eurjchem.5.3.497-502.1080 | Get rights and content
Refbacks
- There are currently no refbacks.
Copyright (c)
© Copyright 2010 - 2023 • 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 2010-2023 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.