Stability - Indicating assay for haloperidol syrup by high-performance liquid chromatography

A Snyder selectivity triangle was approved for the optimization of a reversed-phases HPLC separation of haloperidol, methylparaben and propylparaben in the presence of their degradation products. The degradation products considered were: 4-(4-chlorophenyl)-4-hydroxypiperidine and 4-fluorobenzoic acid presumed to be hydrolytic products of haloperidol, and 4-hydroxybenzoic presumed to be a hydrolytic product of parabens. Separation was achieved on an octadecyl silica column using a mobile phase of methanol, phosphate buffer (pH 2.0) and triethylamine (50:50:0.2) with UV detection at 254 nm. The pro posed method was verified for linearity, specificity accuracy and reproducibility. The stability-indicating capability of the assay was proved by conducting forced degradation conditions of light and temperature on a commercial drug product, for the stability investigation of the active ingredient and preservatives. It was successfully used to proceed the degradation kinetics of the drug under several storage conditions.