Determination of metamizol-Na in suppositories by high performance thin layer chromatography (HPTLC).

A quantitative method for metamizol-Na in suppositories made with Witepsol H-15 as fatty matrix, using High Performance Thin Layer Chromatography (HPT LC) is proposed and validated. Rosemont procedure based on statistical analysis of accuracy, precision, li nearity and proportionality through the analytical assay of six replicates and three concentration levels representing 90, 100 and 110% of declared co ncentration was used. Accordingly validation procedure, the method is convenient and trustful bec ause the Confident Limit of mean includes 100% of recovery, precise (CV = 2 .45), linear (RV = 7.77 < F = 8.66), and proportional since Confident inter val of intercept includes zero. The HPTLC method, proposed for quantitative analysis of metamizol-Na in sup positories do not differ statistically from the Official Method described i n the German Pharmacopeia.