IJOD, 2017, 5(3), 116-123 www.drugresearch.in Indian Journal of Drugs, 2017, 5(3), 116-123 ISSN: 2348-1684 NEW STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF ARIPIPRAZOLE IN BULK AND THEIR FORMULATIONS Mallikarjuna Rao Nagasarapu. 1 *, Gowrisankar Dannana 2 1 Research & Development, Jawaharlal Nehru Technological University, Kakinada- 533003. Andhra Pradesh, India. 2 Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India. *For Correspondence: Research & Development, Jawaharlal Nehru Technological University, Kakinada-533003. Andhra Pradesh, India. ABSTRACT A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of Aripiprazole (ARI) in tablet dosage form. For the HPLC method, Symmetry® C-18 5µ Column consisting of 4.6 × 250 mm internal diameter in isocratic mode, with mobile phase containing Acetonitrile and methanol in the ratio of 35:65 v/v was used. The flow rate was 1mL min-1 and effluent was monitored at 254 nm. Aripiprazole was found to be 4.58±0.40 min, respectively. The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 10 - 100 µg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.4 and 10 µg/ml respectively. No chromatographic interference from tablet excipients was found. The proposed method was successfully used for estimation of ARI in tablet dosage form. KEYWORDS: Aripiprazole, Development and Validation, RP-HPLC, Degradation study Received: 26.04.2017 Accepted: 22.09.2017 Access this article online Website: www.drugresearch.in Quick Response Code: INTRODUCTION Aripiprazole (ARI) is chemically 7-{4-[4-(2,3-dichlorophenyl) piperazin-1-yl]butoxy}-3,4- dihydroquinolin-2(1H)-one. Fig.1 is an typical antipsychotic and antidepressant used in the treatment of schizophrenia, bipolar disorder, and clinical depression 1-2 . Literature survey revealed few analytic methods like HPLC for the estimation of ARI in formulation. Liquid chromatography/mass spectrometry (LC/MS) method has been reported for the determination of ARI in biological fluids 3- 4 The present work describes a novel stability indicating method for the determination of ARI in tablets using reverse phase HPLC. The proposed method was robust and hence suitable for routine determination of the drug in formulation. FIG.1: Chemical structure of aripiprazole