Iloperidone

Iloperidone is a novel antipsychotic drug widely used to treat schizophrenia. Objective of this investigation was to develop a validated stability indicating high performance thin layer chromatographic method for the quantification of iloperidone in bulk and pharmaceutical dosage form. Aluminium backed TLC plates precoated with silica gel 60F-254 was employed as the stationary phase and n-propanol: chloroform (5:5 v/v) as the mobile phase. Densitometric analysis was performed at 275 nm in the reflectance mode. Compact spots of iloperidone with Rf value 0.36 were observed. Validation of the method as per ICH guidelines produced satisfactory results of linearity (r2>0.999), limit of detection (5.349 ng/spot), limit of quantification (16.2099 ng/spot), precision (< 2%), and accuracy (99.66 ±0.341 to 100.34±0.292%). Degradation products were found to be well separated from the pure drug with significantly different Rf values suggesting a stability indicating analysis method for the estimation of iloperidone in pharmaceutical preparations and as bulk drug. The proposed method is selective, sensitive, precise, and accurate. It is also simple, economic and time saving as compared to reported HPLC methods. 

  First and second order derivative UV-Spectrophotometric methods have been developed and validated for the estimation of Iloperidone in bulk and its tablet formulations. The solutions of standard and sample were prepared in methanol. The Iloperidone solution was showed the maximum absorbance at 262nm and 248nm for the first and second order UV-Spectrophotometric methods respectively. Beer’s law was obeyed in the concentration range of 4- 12 μg / ml with r2 value 0.999 for both the methods. These methods were tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation and was found within the range of 0.13 % to 1.7 % for the both methods. Limit of detection was 0.0133 μg/ml (first order), 0.0216 μg/ml (second order) and  limit of quantification was found to be 0.0403 μg/ml (first order), 0.0657 μg/ml (second order). Recovery of Iloperidone was found to be within the range of 99.51 – 100.16 % for the two methods. The proposed methods were successfully applied for the determination of Iloperidone in tablet formulations. In addition, the proposed methods are simple, easy to apply, low cost, and requires relatively inexpensive instruments.