Tue, 19 Dec 2017

Validated Stability Indicating HPTLC method for the Quantitative Estimation of Iloperidone in Pharmaceutical Dosage form

 

A.S. Manjula Devi*1, TK Ravi1

1.Department of Pharmaceutical Analysis, College of Pharmacy, SRIPMS, Coimbatore-641044


 

ABSTRACT

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. 

Keywords: Iloperidone, stability indicating, HPTLC, validation, ICH guidelines, degradation


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