SIMULTANEOUS DETERMINATION AND VALIDATION OF PARACETAMOL AND KETOPROFEN IN PHARMACEUTICAL DOSAGE FORMS BY REVERSE PHASE HPLC METHOD
Dr. Battula Sreenivasa Rao* and K. Nagendra Rao
ABSTRACT
A rapid, specific and accurate isocratic HPLC method was developed and validated for the assay of Paracetamol and Ketoprofen in pharmaceutical dosage forms. The assay involved an isocratic – elution of Paracetamol and Ketoprofen in ODS- C18 column using mobile phase composition consists of 70:30% (v/v) of methanol and 0.1% (v/v) Orthophosphoric acid operated on isocratic mode.The wavelength of detection is 254 nm. The method showed good linearity in the range of 50 to 500 μg/mL for Paracetamol and 20.05 to 200.54 μg/mL for Ketoprofen. The runtime of the method is 7.0 mins. The proposed method can be used for routine quality control samples in industry in bulk and in finished dosage forms. In present study, a rapid specific precise and validated HPLC method for the quantitative estimation of Paracetamol and Ketoprofen in pharmaceutical dosage forms has been reported. The developed method can be applied to directly and easily to the analysis of the pharmaceutical tablet preparations. The percentage recoveries were near 100% for given methods. The method was completely validated and proven to be rugged. The excipients did not interfere in the analysis. The results showed that this method can be used for rapid determination of Paracetamol and Ketoprofen in pharmaceutical tablet with precision, accuracy and specificity.
Keywords: Paracetamol and Ketoprofen, HCL, Assay, Reverse phase, HPLC.
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