Spectrophotometric procedures for the determination of roxithromycin in pharmaceutical formulations

Four simple and sensitive visible spectrophotometric procedures for the assay of roxithromycin (RXT) have been developed. Procedures A and B are based on the formation of ion-pairs of roxithromycin with the dyes supracen violet 3B and tropaeolin 000, which are extracted into chloroform and have absorption maxima at 590 nm (SV 3B) and 490 nm (TP 000). Procedures C and D are based on condensation between the hydrolysis product of RXT in the presence of 3.6M hydrochloric acid in acetic acid medium and vanillin orp-dimethylaminobenzaldehyde (PDAB) to form coloured products with _max at 500 nm. Regression analysis of the Beer's plot showed good correlation in the concentration ranges 5–60 (A), 5–40 (B) and 5–50 (C & D) g/ml. No interference was observed from excipients and the validity of the procedures was tested by analysing pharmaceutical formulations. Recoveries were 99.0–102.0%. The concentration measurements are reproducible within a relative standard deviation of 1.0%.