Der Pharmacia Lettre
Abstract
Author(s): G. Saravanan, Mohammad Yunoos, and B. Pooja
To develop a simple, sensitive, specific, precise and accurate stability indicating RP-HPLC method and subsequent
validation of the method for the simultaneous estimation of paracetamol, aceclofenac and rabeprazole sodium in
bulk and combined tablet dosage form. The chromatographic separation was carried out using waters 2675 HPLC
separation module equipped with Agilent CN column (250 X 4.6mm, 5�Ž�¼ particle size) and mobile phase consisting
of ammonium acetate buffer (pH adjusted to 7.5 with ammonia solution) and acetonitrile in the ratio of 70:30 % v/v
at a flow rate of 1.0 ml/min was used. UV detection was carried out at 213 nm. The retention time of paracetamol,
aceclofenac and rabeprazole sodium was found to be 3.678, 5.556 and 9.572 min respectively. The developed
method illustrated excellent linearity in the concentration range of 16-488 �Ž�¼g/ml for paracetamol, 5-150 �Ž�¼g/ml for
aceclofenac and 0.5-16.8 �Ž�¼g/ml for rabeprazole sodium respectively. Drugs were subjected to stress conditions
including acidic, alkaline, oxidation, photolysis and thermal degradation. No chromatographic interference from
the tablet excipients was found. The % recoveries were found to be 100.45 % for paracetamol, 100.47 % for
aceclofenac and 100.47 % for rabeprazole sodium respectively which shows accuracy of the method. The developed
method was validated in accordance with ICH guidelines and was found to be accurate, precise, reproducible and
specific and can be successfully applied for the quantitative estimation of paracetamol, aceclofenac and rabeprazole
in bulk and pharmaceutical dosage form and in routine quality control analysis.
