Sun, 17 Dec 2017

A Validated RP-HPLC Method for the Estimation of Paliperidone in Bulk and Tablet Dosage Form

A. S. Manjula Devi*, T. K.  Ravi

 

1. Department of Pharmaceutical Analysis, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore-641 044

 


ABSTRACT

A novel, precise and selective high performance liquid chromatographic method was developed for the estimation of paliperidone using paracetamol as the internal standard. Separation was achieved on a LiChrospher® RP-18 HPLC column (5 μ particle size and 25 cm × 4.6 mm internal diameter) using 10 mM ammonium acetate: methanol in the ratio of 10:90 (v/v) as the mobile phase, at flow rate of 0.7 ml/min and the eluate was monitored at 277 nm. The method was validated in compliance with ICH guidelines. The correlation coefficient of the calibration graph was 0.99946±0.00037 over the concentration range 1 to 5 µg mL-1. The limit of detection and limit of quantification were 0.569 µg mL-1 and 1 µg mL-1, respectively. Overall percentage recovery of paliperidone ranged between 98.92±0.595 to 100.30±0.693. Relative standard deviations for intra- and inter-day precision studies were <2%. The method was simple, rapid, economic and suitable for the regular quality control of paliperidone in tablet dosage forms.   

Keywords: Paliperidone, RP-HPLC, paracetamol, validation, ICH guidelines


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