PHARMACEUTICAL ANALYSIS OF BETA-METHYLDIGOXIN IN DOSAGE FORMS USING RP-HPLC

A reversed-phase high-performance liquid chromatographic method has be en developed for the assay of beta-methyldigoxin in Dimekor(R) tablets (0.1 mg) and ampules (0.2 mg/2 mL). Quantitation of cardiac glycoside in mentioned dosage forms was carried out by the incorporation of phe nacetin as an internal standard. A Varian PD?LC configured with a Part isil P10 ODS1 column was used for the separation and quantitation of b eta-methyldigoxin in pharmaceutical preparations. The mobile phase was acetonitrile-water 38 : 62 v/v with flow rate 1.6 ml/min and UV detec tion was set at 220 nm. The range of Linearity extended from 0.01 to O .11 mg/mL. For the quantitative analysis of beta-methyldigoxin in tabl ets the recovery was 100.16 % and for ampules 99.50 %. The excipients did not interfere with tile determination of the analysed substance. T he proposed method is precise and sensitive for the examination of exa mine the content uniformity of tablets and is in a good agreement with PH.JUG.IV (1). A spectrofluorimetric method was used for the dissolut ion test by the method described in USP XXII (2).