Requirements for drug active substances are specified in documents from International Conference of Harmonization. According to these guidelines quality of the pharmaceutical compounds must be confirmed by validated analytical methods [1,2].

The quality of pioglitazone hydrochloride batches manufactured in Pharmaceutical Research Institute was examined by the following methods:

• Gas Chromatography (GC) was used for the quantitative determination of the following solvents: 2-propanol, acetone, acetic acid.
• High Performance Liquid Chromatography (HPLC) was used for determination of the purity and quantity of the active substance,
• Potentiometric titration was used for quantitative determination of chloride anion.

Adapted methods were validated to prove that all the procedures used to generate analytical data are suitable for their purpose.

[1] Dyrektywa 75/318/EEC z aneksem 91/507/EEC.

[2] J. Pawlaczyk, M. Zając, "Walidacja metod analizy chemicznej - przykłady walidacji metod", AM Poznań 2005, wyd. 3

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