HPLC-UV DETERMINATION OF INDAPAMIDE IN THE PRESENCE
OF ITS MAIN SYNTHESIS AND DEGRADATION IMPURITIES.
METHOD VALIDATION

SIMONA CODRUȚA HEGHEȘ1#, LUCIA MARIA RUS1#, LUCA-LIVIU RUS2*, MARIUS TRAIAN BOJIȚĂ1, CRISTINA ADELA IUGA1,3
1Department of Drug Analysis, Faculty of Pharmacy, “Iuliu Hațieganu” University of Medicine and Pharmacy, 6 Pasteur
Street, Cluj-Napoca, Romania
2Preclinical Department, Faculty of Medicine, “Lucian Blaga” University, 2A Lucian Blaga Street, Sibiu, Romania
3Proteomic and Metabolomic Department, MedFUTURE - Research Centre for Advanced Medicine, “Iuliu Hațieganu”
University of Medicine and Pharmacy, 4-6 Louis Pasteur Street, 23 Marinescu Street, Cluj-Napoca, Romania
*corresponding author: liviu.rus@ulbsibiu.ro
#Authors with equal contribution.
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Abstract:
A gradient HPLC with UV detection method was developed for the quantitative determination of indapamide in the presence
of 6 of its synthesis and degradation impurities. The separation of analytes was performed on X-Terra, C18, 250 mm × 4.6
mm, 5 μm (Waters) column using a mixture of aqueous Na2EDTA, acetonitrile and methanol, with detection at 254 nm. The
developed method was validated and is suitable for in process purity evaluation of indapamide synthesis, indapamide stability
in bulk and in pharmaceutical dosage forms.






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