Development and Validation of a New HPLC Method for In-vitro Studies of Haloperidol in Solid Lipid Nanoparticles

Abstract

A simple and sensitive HPLC method was developed and validated for the study of in-vitro drug release from haloperidol loaded solid lipid nanoparticles (SLNs). The method was also used for the analysis of drug for detection of shelf life of developed SLNs. Chromatogram separation was achieved using C18 column as stationary phase. The mobile phase consisted of 100 mM/L potassium dihydrogen phosphate–acetonitrile-TEA (10:90:0.1, v/v/v) and the pH was adjusted with o-phosphoric acid to 3.5. Flow rate of mobile phase was 2 ml/minute and eluents were monitored at 230 nm using UV/VIS detector. The method was validated for linearity, precision, accuracy, reproducibility, limit of detection (LOD) and limit of quantification (LOQ). Linearity for haloperidol was in the range of 1-60 μg/mL. The value of LOD and LOQ was found to be 0.045 and 0.135 μg/ml respectively. The drug loaded SLNs showed sustained drug release with maximum value of 95.52 ± 5.21% in 24 h. The shelf life of SLNs formulation was found to be 2.31 years at 4°C.