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Abstract

A REVIEW ON ANALYTICAL METHOD VALIDATION OF DICLOFENAC SODIUM AND PARACETAMOL TABLET DOSAGE FORM

Rajarshee K. Patel*, Kaushik R. Patel, Jaymin G. Patel, Ronak Patel and Dr. Yogesh Patel

ABSTRACT

 Two Simple, Specific, Sensitive, coast effective, time efficient & accurate methods are described for the simultaneous determination of Paracetamol and Diclofenac in combined tablet dosage form. First method is simultaneous question method is based on absorption by UV Visible Spectrophotometric method. The absorption maxima of drugs were found to be at 247 nm for Paracetamol and 276 nm for Diclofenac Sodium. Second method is a simple, specific, accurate, coast effective & time efficient reverse phase high performance liquid chromatographic method was developed for the simulation determination of Paracetamol and Diclofenac using RP-18 (4.6 mm X 2.5 cm) column and a mobile phase composed of Acetonitrile: Methanol (90:10 v/v) at flow rate 1 ml/min. The rational time of Paracetamol and Diclofenac Sodium were found to be 2.8 min and 3.9 min respectively. Simultaneous equation method and Q-analysis method have been used in the estimation of both the drugs. Both the methods show good accuracy and precision which was validated statistically. These methods require no preliminary separation and can therefore be used for routine analysis of both drugs in quality control laboratories.  The second method was developed for the simultaneous determination of Paracetamol and Diclofenac, using RP-18 (4.6 mm X 2.5 cm) column and a mobile phase composed of Acetonitrile: Methanol (90:10 v/v) at flow rate 1 ml/min. The retention time of Paracetamol and Diclofenac were found to be 2.8 min and 3.9 min respectively which is much less than the other method used for the estimation of Paracetamol and Diclofenac. Linearity was established for Paracetamol and Diclofenac in the range 20 – 200 μg / ml and 300- 500 μg / ml respectively. The percentage recoveries of Paracetamol and Diclofenac were found to be in the range 99.56% and 103.05% respectively. The proposed method is precise, accurate, selective and rapid for the simultaneous determination of Paracetamol and Diclofenac for QC level.

Keywords: Diclofenac Sodium, Paracetamol, RP-HPLC, UV Visible Spectrophotometric, Simultaneous equation method.


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