Development and validation of RP-HPLC method for loxapine in capsule dosage form

Abstract

A reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for the determination of loxapine drug in tablet dosage form. The developed method was validated by measuring linearity, precision, limit of detection (LOD), robustness and ruggedness, drug recovery and for system suitability. Water and acetonitrile in the ratio 55:45 v/v was the mobile phase with C 18 column (250 mm x 4.5 mm x 5 µm) as a stationary phase and 265 nm was the detection wavelength. The HPLC system was operated in isocratic mode. The measured retention time of loxapine drug was 6.88 minutes and the limit of detection was 0.035 µg/ml, respectively. The linearity measured in the range 10-100 µg/ml had a correlation coefficient of 0.999. The results of the parameters precision, robustness, recovery and formulation assay indicate that the developed method is a very good tool for the analysis of loxapine drug in tablet dosage form in bulk.