European Journal of Chemistry

Development and validation of a new RP-HPLC method for the determination of process related impurities in pioglitazone hydrochloride

Article Sidebar

PDF
Published: Sep 30, 2014
DOI: https://doi.org/10.5155/eurjchem.5.3.469-474.1058
Keywords:
RP-HPLC, Thiazolidinedione, Method development, Forced degradation study, Process related impurities, Pioglitazone hydrochloride
Section
Research Article
Issue
Vol. 5 No. 3 (2014): September 2014
Dates
Received 2014-03-22
Accepted 2014-05-04
Published 2014-09-30


Main Article Content

Venkata Raj Kumar Prava
Department of Pharmaceutical Sciences, Andhra University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, 530003, Andhra Pradesh, India
Ganapaty Seru
Gitam Institute of Pharmacy, Gitam University, Rushikonda, Visakhapatnam, 530045, Andhra Pradesh, India

Abstract

A reversed phase high performance liquid chromatographic method for the determination of process related impurities in pioglitazone hydrochloride was developed and validated. High-quality separation was achieved on a Luna C18 column (150 mm × 4.6 mm, 3 µm) using gradient elution at a flow rate of 1 mL/min and a column temperature of 45 °C. UV detection was performed at 254 nm. The validation was performed according to the International Conference on Harmonization (ICH) guidelines. In addition, the solution stability and method robustness were examined. The method gives satisfactory separation of impurities of pioglitazone hydrochloride and so it is suitable for quantification of the process related impurities as well as for the assay of the active compound.


icon graph This Abstract was viewed 1416 times | icon graph Article PDF downloaded 854 times

How to Cite
(1)
Prava, V. R. K.; Seru, G. Development and Validation of a New RP-HPLC Method for the Determination of Process Related Impurities in Pioglitazone Hydrochloride. Eur. J. Chem. 2014, 5, 469-474.

Article Details

Share
Links for Article


Crossref - Scopus - Google - European PMC
Crossref
Scopus
Google Scholar
Europe PMC
References

[1]. Gillies, P. S.; Dunn, C. J. Drugs. 2000, 60, 333-343.
http://dx.doi.org/10.2165/00003495-200060020-00009

[2]. Diamant, M.; Heine, R. J. Drugs. 2003, 63, 1373-1405.
http://dx.doi.org/10.2165/00003495-200363130-00004

[3]. Madan, P. CMAJ 2005, 173, 344-345.
http://dx.doi.org/10.1503/cmaj.1050034

[4]. Brunton, L. L.; Lazo, J. S.; Parker, K. L. Goodman & Gilman's the pharmacological basis of therapeutics. 10th Edi. New York, McGraw-Hill, 2001.

[5]. Lacy, C. F.; Armstrong, L. L.; Goldman, M. P.; Lance, L. L. Drug information handbook 2000-2001. 8th Edi. Cleveland, Lexi-Comp., 2000.

[6]. Eckland, D. A.; Danhof, M. Exp. Clin. Endocrinol. Diab. 2000, 108, 234-242.
http://dx.doi.org/10.1055/s-2000-8525

[7]. Colca, J. R.; McDonald, W. G.; Waldon, D. J.; Leone, J. W.; Lull, J. M.; Bannow, C. A.; Lund, E. T.; Mathews, W. R. Am. J. Physiol. Endocrinol. Metab. 2004, 286(2), 252-260.
http://dx.doi.org/10.1152/ajpendo.00424.2003

[8]. Paddock, M. L.; Willy, S. E.; Axelrod, H. L.; Cohen, A. E.; Roy, M.; Abresch, E. C.; Capraro, D.; Murphy, A. N. Proc. Natl. Acad. Sci. U. S. A. 2007, 104(36), 14342-14347.
http://dx.doi.org/10.1073/pnas.0707189104

[9]. The Merck Index, 14th Edi. Merck and Co Inc., NJ, USA, 2006.

[10]. URL: http://www.rxlist.com/actos-drug.htm

[11]. Zhong, W. Z.; Williams, M. G. J. Pharm. Biomed. Anal. 1996, 14, 465-473.
http://dx.doi.org/10.1016/0731-7085(95)01665-1

[12]. Yamashita, K.; Murakami, H.; Okuda, T.; Motohashi, M. J. Chromatogr. B. 1996, 677, 141-146.
http://dx.doi.org/10.1016/0378-4347(95)00440-8

[13]. Radhakrishna, T.; Sreenivas, R. D.; Reddy, O. G. J. Pharm. Biomed. Anal. 2002, 29, 593-607.
http://dx.doi.org/10.1016/S0731-7085(02)00036-5

[14]. Xue, Y. J.; Turner, K. C.; Meeker, J. B.; Pursley, J.; Arnold, M.; Unger, S. J. Chromatogr. B. 2003, 795, 215-226.
http://dx.doi.org/10.1016/S1570-0232(03)00575-0

[15]. Sane, R. T.; Menon, S. N.; Inamdar, S.; Mote, M.; Gundi, G. Chromatographia 2004, 59, 451-453.
http://dx.doi.org/10.1365/s10337-004-0209-9

[16]. Sripalakit, P.; Neamhom, P.; Saraphanchotiwitthaya, A. J. Chromatogr. B 2006, 843, 164-169.
http://dx.doi.org/10.1016/j.jchromb.2006.05.032

[17]. Lotfy, S. A. M. R. Pak. J. Anal. Environ. Chem. 2008, 2(9), 118-121.

[18]. Tahmasebi, E.; Yamini, Y.; Saleh, A. J. Chromatogr. B 2009, 877, 1923-1929.
http://dx.doi.org/10.1016/j.jchromb.2009.05.033

[19]. Cijo, M. X.; Kanakapura, B. ISRN Chromatography. 2012, 592849, 1-11.

[20]. Venugopal, S.; Kalpana, S.; Jagadishbabu, A.; Upendra, M. T.; Devanna, N. Int. J. Pharm. Biomed. Sci. 2012, 3(3), 89-96.

[21]. Ramzia, I.; El-Bagary, E.; Elkady, F.; Bassam, M. A. Int. J. Biomed. Sci. 2011, 7(3), 201-208.

Supporting Agencies

Pharmazell Research Centre, Visakhapatnam, 530003, Andhra Pradesh, India
Most read articles by the same author(s)
TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution, or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).