Assessment of Related Substances in Pioglitazone Hydrochloride by HPLC Method


 The goal of this study was to design and validate an efficient, high-performance liquid chromatographic method for quantifying associated chemicals in pioglitazone hydrochloride medicinal material.

The determination of three related compounds in pioglitazone hydrochloride is part of this approach. The mobile phase A is 0.1 percent w/v triethylamine in water with dilute phosphoric acid to adjust the pH to 2.5. Premixed and degassed acetonitrile and methanol mixtures make up the mobile phase B. The flow rate was 1 millilitre per minute. Gradient mode elution was utilised. The analysis was performed on a symmetric C18 HPLC column with a length of 250 mm, an internal diameter of 4.6 mm, and a particle size of 5.0 microns.

The devised approach was shown to be linear with a coefficient of correlation of 0.99 and a range of 0.006-250 percent. The % relative standard deviation was found to be within the permissible range in the precision study. The contaminants had a limit of detection and a limit of quantitation of less than 0.002 percent and 0.006 percent, respectively, at a pioglitazone hydrochloride test concentration of 2000 g/ml. This approach has been validated in accordance with ICH Q2 requirements (R1). PGR-II and PIO-II were process-related impurities, while N-oxide was a degradation impurity, according to the method’s specificity, solution stability, and robustness. This means the equipment was appropriate, accurate, exact, sensitive, and acceptable for research.

Conclusion: For quantitative analysis of associated components of pioglitazone hydrochloride medicinal material, a reliable and cost-effective HPLC technique was brilliantly established.

Author(s) Details:

N. Balaji,
Department of Chemistry, St. Peter’s University, Avadi, Chennai-600054, Tamil Nadu, India.

Sayeeda Sultana,
Department of Chemistry, St. Peter’s University, Avadi, Chennai-600054, Tamil Nadu, India.

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