Article Quantitative Determination of Olanzapine in Pharmaceutical Preparations by HPLC

Abstract. A new high performance liquid chromatographic (HPLC) method in reverse phase was developed and validated for the determination of olanzapine (OLZ) in pharmaceutical formula-tions. Optimum separation was achieved in less than 10 min using a reversed phase Intersil ODS column (150 mm × 4.6 mm, i.d., particle size 5 mm), and elution was accomplished using a mobile phase (0.5 mL/min). Detection was carried out using a UV detec-tor set at 271 nm. A rectilinear relationship between mean peak area and concentration of OLZ was observed in the range 10-200 mg/mL, with a detection limit of 3.0 mg/mL and a quantization limit of 8.0 mg/mL. Intra-day and Inter-day precision, and accuracy of the methods have been established according to the current ICH guidelines. The developed method was successfully applied to the determination of OLZ in pharmaceutical formulations. The results were statistically compared with those of the reference method b