European Journal of Chemistry 2014, 5(3), 469-474. doi:10.5155/eurjchem.5.3.469-474.1058

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


Venkata Raj Kumar Prava (1,*) , Ganapaty Seru (2)

(1) Department of Pharmaceutical Sciences, Andhra University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, 530003, Andhra Pradesh, India
(2) Gitam Institute of Pharmacy, Gitam University, Rushikonda, Visakhapatnam, 530045, Andhra Pradesh, India
(*) Corresponding Author

Received: 22 Mar 2014, Accepted: 04 May 2014, Published: 30 Sep 2014

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.


Keywords


RP-HPLC; Thiazolidinedione; Method development; Forced degradation study; Process related impurities; Pioglitazone hydrochloride

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DOI: 10.5155/eurjchem.5.3.469-474.1058

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How to cite


Prava, V.; Seru, G. Eur. J. Chem. 2014, 5(3), 469-474. doi:10.5155/eurjchem.5.3.469-474.1058
Prava, V.; 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(3), 469-474. doi:10.5155/eurjchem.5.3.469-474.1058
Prava, V., & Seru, G. (2014). Development and validation of a new RP-HPLC method for the determination of process related impurities in pioglitazone hydrochloride. European Journal of Chemistry, 5(3), 469-474. doi:10.5155/eurjchem.5.3.469-474.1058
Prava, Venkata, & Ganapaty Seru. "Development and validation of a new RP-HPLC method for the determination of process related impurities in pioglitazone hydrochloride." European Journal of Chemistry [Online], 5.3 (2014): 469-474. Web. 17 Sep. 2019
Prava, Venkata, AND Seru, Ganapaty. "Development and validation of a new RP-HPLC method for the determination of process related impurities in pioglitazone hydrochloride" European Journal of Chemistry [Online], Volume 5 Number 3 (30 September 2014)

DOI Link: https://doi.org/10.5155/eurjchem.5.3.469-474.1058

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