Pharmaceutical Analysis of β-Methyldigoxin in Dosage Forms Using RP-HPLC

Abstract

A reversed-phase high-performance liquid chromatographic method has been developed for the assay of β-methyldigoxin in Dimekor® 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 phenacetin as an internal standard. A Varian HPLC configured with a Paltisil P10 ODS1 column was used for the separation and quantitation of β-methyldigoxin in pharmaceutical preparations. The mobile phase was acetonitrile-water 38: 62 v/v with flow rate 1.6 ml/min and UV detection was set at 220 nm. The range of linearity extended from 0.01 to 0.11 mg/mL. For the quantitative analysis of β-methyldigoxin in tablets the recovery was 100.16% and for ampules 99.50%. The excipients did not interfere with the determination of the analysed substance. The proposed method is precise and sensitive for the examination of examine the content uniformity of tablets and is in a good agreement with PH.JUG.IV (1). A spectrofluorimetric method was used for the dissolution test by the method described in USP XXII (2).