Romanian Society of Pharmaceutical Sciences

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

SIMONA CODRUȚA HEGHEȘ 1#, LUCIA MARIA RUS 1#, LUCA-LIVIU RUS 2*, MARIUS TRAIAN BOJIȚĂ 1, CRISTINA ADELA IUGA 1,3

1.Department of Drug Analysis, Faculty of Pharmacy, “Iuliu Hațieganu” University of Medicine and Pharmacy, 6 Pasteur Street, Cluj-Napoca, Romania
2.Preclinical Department, Faculty of Medicine, “Lucian Blaga” University, 2A Lucian Blaga Street, Sibiu, Romania
3.Proteomic 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

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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.