Abstract

The chemical stability of haloperidol lactate injection was studied under different storage conditions by high performance thin-layer chromatography (HPTLC). The study was performed at 25 ± 2°C and at refrigeration temperature (8 ± 1°C) in original glass ampoules over 15 days after being opened. The samples tested at 25 ± 2°C were stored with exposure to and protection from light. Chromatographic separation was achieved on precoated silica gel F 254 HPTLC plates using a mixture of acetone/chloroform/n-butanol/glacial acetic acid/water (5:10:10:2.5:2.5, v/v/v/v/v) as a mobile phase. Quantitative analyses were carried out at a wavelength of 254 nm. The method exhibited adequate linearity (r = 0.999), selectivity, precision (RSD = 1.92%), and accuracy (recoveries from 98.59 to 101.90%). The concentrations of all samples remained greater than or 90% of the original concentration. Haloperidol lactate injection was chemically stable under all conditions studied over 15 days. © 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.