Investigation of the chemical equivalence of the trypanocidal products, Samorin (R) and Veridium (R)

A procedure for the evaluation of chemical equivalence of proprietary formu lations of isometamidium is described. The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substanc es and determination of the inorganic impurity, ammonium chloride, using a modification of the Berthelot (Indophenol) reaction. Application of these p rocedures to analyses of commercially available sachets from four different batches of Samorin(R) and four different batches of Veridium(R) has demons trated that there are marked qualitative and quantitative differences betwe en batches from these two sources. Whilst Samorin(R) samples showed inter-b atch consistency of composition, there was considerable inter-batch variati on between the samples of Veridium(R). (C) 1999 Elsevier Science B.V. All r ights reserved.