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Stability Indicating Chromatographic Method Development and Validation for the Simultaneous Determination of Ilaprazole and Domperidone in Its Pharmaceutical Dosage Form by RP- HPLC

Priyanka Mavji Patel* , Priyanka Mavji Patel* , Gali Vidya Sagar** , Chirag Jayatilal Patel***

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Journal of Pharmaceutical and Medicinal Chemistry 2(1):p 85-93, January - June 2016. | DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.2116.8

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Abstract

 A specific, accurate, precise and reproducible RP HPLC method has been developed and subsequently validated for the simultaneous estimation of Ilaprazole and Domperidone in pharmaceutical dosage form. The proposed HPLC method utilizes hypersil (Thermo scientific) C18 column (250 mm × 4.6 mm id, 5 ìm particle size), and mobile phase consisting of water: Acetonitrile: Acetic acid (30:70:0.1) at a flow rate of 1.0 mL/ min. Quantitation was achieved with PDA detection at 255 nm based on peak area with linear calibration curves at concentration ranges 5-15 g/ ml for Ilaprazole and 15-45 g/ml for Domperidone. The retention time of Ilaprazole and Domperidone were found to be 3.753 min and 6.120 min respectively. The stability studies were carried out and method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. This method has been successively applied to marketed formulation and no interference from the formulation excipients was found. 

Keywords: Ilaprazole; Domperidone; Stability Indicating Assay; HPLC.

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DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.2116.8

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