High-performance thin-layer chromatographic determination of diltiazem hydrochloride as bulk drug and in pharmaceutical preparations

Abstract

A simple, rapid, selective and precise high-performance thin-layer chromatographic method for the analysis of diltiazem hydrochloride both as a bulk drug and in pharmaceuticals is reported. The mobile phase composition was ethyl acetate–methanol–strong ammonia solution (80:10:10, v/v). Densitometric analysis of diltiazem hydrochloride was carried out at 238 nm. The calibration curve of diltiazem hydrochloride in distilled water was linear in the range 40–400 ng. The mean value of correlation coefficient, slope and intercept were 0.997±0.0008, 0.0617±0.0012 and 7.16±0.2562, respectively. The limits of detection and quantitation were 20 ng and 40 ng, respectively. The recovery of diltiazem hydrochloride was about 99.5%. The method was utilized to analyse diltiazem hydrochloride from conventional and sustained release tablets in the presence of commonly used excipients.