METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL ACECLOFENAC AND CHLORZOXAZONE IN A PHARMACEUTICAL DOSAGE FORM
J. Jayashree*, S. S. Rajendran and N. Santhi
ABSTRACT
In the present investigation, a simple and accurate reverse-phase high performance liquid chromatography method has been developed for simultaneous estimation of Paracetamol (PAR) and Aceclofenac (ACF) and Chlorzoxazone (CHZ) in tablet dosage form by Isocratic elution. The chromatographic separation was performed on a Nucleodur, C 18,250 x 4.6 mm column. The mobile phase consists of Buffer:Methanol (50:50, pH adjusted with orthophosphoric acid), maintaining the flow rate at 0.8 mL/minute. The quantification was achieved with UV detection at 270nm for 8 minutes later adjusted to 220nm. The retention time acquired for PAR was 3.361 CHZ was 11.281 and ACF was 5.638 min in a continuous run up to 20 min. The detector response was found to be linear in the concentration range of
30-45 μg/ml for PAR, 40-60 μg/ml for CHZ and 8-12 μg/ml for ACF. The developed method is simple, accurate, precise, linear, specific and robust .This method may be recommended for the routine analysis in combined dosage forms and can be used for wash analysis. According to ICH guidelines the developed method was validated. The proposed method can be used for estimation of these drugs in combined pharmaceutical dosage forms.
Keywords: Paracetamol, Aceclofenac and Chlorzoxazone RP-HPLC, Development, Validation.
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