RP-HPLC Method Development and Validation for Estimation of Aripiprazole in Bulk and Dosage Form

Author(s): Sonali N. Kawade*, Jaiprakash V.Kokane , Bhavana A. Kokane and Rameshwar B. Dhule

Abstract: A simple, rapid, sensitive, reverse phase high performance liquid chromatographic method was developed for estimation of aripiprazole in bulk & dosage form. The method was validated as per ICH guidelines. Aphenomenex C18 (250mm X 4.6mm,5μm).The mobile phase for estimation is phosphate buffer (PH 4.2)70: Methanol 30 and detection was carried out 255nm.The analysis was performed runtime 7min at a flow rate 1ml/min. Linearity was obtained in concentration range of 10 to 60 μg/ml with correlation coefficient 0.9997 respectively. The method was validated for precision. Limit of detection, limit of quantitation, linearity, robustness and ruggedness. The limit of quantitation and limit of detection was found to be 3.72μg/ml to 1.23μg/ml respectively. Proposed HPLC method was sensitive and reproducible for the analysis of aripiprazole in pharmaceutical dosage form (tablet) with short analysis time.

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