Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Paracetamol and Flupirtine Maleate in Pharmaceutical Dosage Form

Abstract:

Objective: To develop and validate a simple, efficient and reproducible RP-HPLC method for the simultaneous determination of paracetamol and flupirtine maleate in bulk and in pharmaceutical formulations. Materials and Method: The chromatographic analysis was performed on a Thermo BDS hypersil C₁₈ (250 x 4.6 mm i.d, 5μ) column in isocratic mode using water: methanol(pH was adjusted to 3.35± 0.02 with ortho-phosphoric acid) in the ratio of 50:50 v/v as eluent. The flow rate was 1 ml/min and eluent was detected at 250 nm. The retention time of paracetamolandflupirtine maleate were 3.5 and 5.4 min, respectively. Results: The linear dynamic range was 650-1950 μg/ml and 200-600 μg/ml for paracetamol and flupirtine maleate, respectively. Percentage recoveries for paracetamol and flupirtine maleate were 100.50 and 99.76 %, respectively. Conclusion: All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of paracetamol and flupirtine maleate in tablet dosage forms.

Key words: Accuracy, flupirtine, paracetamol, validation.