HPTLC and HPLC determination of isometamidium in the presence of its manufacturing and degradation impurities

J Pharm Biomed Anal. 1998 Aug;17(4-5):713-8. doi: 10.1016/s0731-7085(98)00008-9.

Abstract

The determination of the phenanthridine trypanocide, isometamidium chloride hydrochloride (ISM), in the presence of four process-related and degradation impurities, by RP-HPLC using a Licrospher-60 RP-select B column with a mobile phase composition of acetonitrile/KH2PO4 (PH 3.0, 20 mM) (25:75 v/v) with UV detection at 320 nm, is described. The method is selective, reproducible and precise with a limit of detection of 45 ng ml-1 for ISM. A HPTLC system (Kieselgel 60 F254, pyridine/acetonitrile/butanol/formic acid, 6:6:4:1, v/v), with UV densitometric evaluation at 320 nm, suitable for the separation of ISM and the related substances is reported.

MeSH terms

  • Chromatography, High Pressure Liquid / methods*
  • Chromatography, Thin Layer / methods*
  • Drug Contamination*
  • Phenanthridines / analysis*
  • Phenanthridines / chemistry
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Spectrophotometry, Ultraviolet
  • Trypanocidal Agents / analysis*
  • Trypanocidal Agents / chemistry

Substances

  • Phenanthridines
  • Trypanocidal Agents
  • isometamidium chloride