Abstract
APPLICATION OF QUALITY BY DESIGN APPROACH FOR DEVELOPMENT OF ANALYTICAL PR-HPLC METHOD FOR ESTIMATION OF ILOPERIDONE IN API AND ITS BULK DOSAGE FORM

Rutuja S. Aher*, Shekhar B. Kale* and Deeliprao V. Derle

ABSTRACT

The aim of the present study was to facilitate investigating the determination of Iloperidone in bulk drug and its pharmaceutical formulations by a developed and validated rapid reverse phase high performance liquid chromatography (RP-HPLC) method. The method was developed using QbD principles and design space (method operable design region) is defined. Suitable working point within design space was selected for validation and validated as per current guidelines. The calibration was linear in the range of 20-120 μg/ml. The relative standard deviation (RSD) percentage for accuracy, precision and robustness was observed within the range of 0.1 and 2.0. Hence, the method is found to be accurate, precise and robust. Accuracy carried by recovery method. System suitability parameters like asymmetry factor and theoretical plate number were found to be within USP acceptance criteria. The validated limit of quantitation (LOQ) 9.6114 μg/ml and limit of detection (LOD) of 3.17 μg/ml are low enough to allow determination of low concentrations of the drug. The assay result of marketed formulation was found to be 99.351%. The proposed method can be used for routine analysis in quality control laboratories for its bulk and formulated product.

Keywords: HPLC, Iloperidone, Quality by Design, Validation.


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