Quantitative Determination of Acetaminophen in the Tablet Dosage Forms by RP-HPLC Method Without Using Buffers

Abstract

The objective of this paper is to develop a method for the determination of acetaminophen in tablets locally available from the pharmacist. We have used a 1220 infinity II LC system of Agilent technologies consisting of a gradient pump with a degasser, variable wavelength detector, Eclipse plus C-18 RP column of size 4.6×250mm, 5 μ. A mixture of methanol–water (30:70 v/v) was used as a mobile phase with a flow rate of 1.0 ml min⁻¹. The separation of acetaminophen was achieved without the use of buffers in the mobile phase. The detector was set at the range of 243 nm. This method was linear over a range of 1-50 µg/ml with correlation coefficients of 0.9998. The average retention time for paracetamol was found to be 4.48 ± 0.03 min. The detection limit and quantitation limit for paracetamol are 0.857 µg/ml and 2.597 µg/ml. The intra-day and inter-day precision expressed as percent relative standard deviation was below 2%. The mean recovery of paracetamol in the dosage form was found to be in the range of 96.0-102.4%. The method can be useful in the validation of tablet dosage forms containing acetaminophen without buffer. The proposed method for drug quantitation is economical, accurate, and rapid