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Original Article

J Med Allied Sci. 2013; 3(1): 8-14

Method development and validation of paracetamol drug by RP-HPLC

T. A. Phazna Devi, Aravind Setti, S. Srikanth, Sivaramaiah Nallapeta, Smita C. Pawar, J. Venkateshwara Rao.


A simple and reproducible method was developed for paracetamol by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Paracetamol was separated on C18 column [4.6x250mm, particle size 5μm], using ortho phosphoric acid buffer with pH of 3.5 at the UV detection of 207nm. Isocratic elution of acetonitrile (ACN) and water was used as a mobile phase with various ratios and flow rates, eventually 25:75 v/v ACN and water was being set with the flow rate of 1mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, further the limit of detection and limit of quantification of paracetamol concentrations were found to be 120ng/mL and 360ng/mL. Recovery and assay studies of paracetamol were within 99 to 102% indicating that the proposed method can be adoptable for quality control analysis of paracetamol.

Key words: RP-HPLC, Validation, Paracetamol, Acetonitrile

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