European Journal of Chemistry

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

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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.


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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.

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Pharmazell Research Centre, Visakhapatnam, 530003, Andhra Pradesh, India
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