Quantitative Determination of Olanzapine in Pharmaceutical Preparations by HPLC
Keywords:olanzapine, quantification, HPLC, pharmaceuticals
A new high performance liquid chromatographic (HPLC) method in reverse phase was developed and validated for the determination of olanzapine (OLZ) in pharmaceutical formulations. Optimum separation was achieved in less than 10 min using a reversed phase Intersil ODS column (150 mm Å~ 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 detector 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 by applying Student’s t-test and F-test. Accuracy, evaluated by means of the spike recovery method, was in the range 97.7-102.3%, with precision (RSD) better than 2%. No interference was observed from the coformulated substances. The method was economical in terms of the time taken and the amount of solvent used.
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