Objective: The objective of the proposed method was to develop a simple, fast, sensitive, and validated high-performance liquid chromatography (HPLC) method for the simultaneous estimation of Paracetamol and Flupirtine Maleate in combined-dosage form. Materials and Methods: A Hypersil BDS C18, 150x4.6, 5µcolumn with mobile phase containing Phosphate buffer (Ph 6.2): Acetonitrile (600:400) was used. The flow rate was 1.0 mL/min, column temperature was 30°C and effluents were monitored at 245 nm. The retention times of Paracetamol and Flupirtine Maleate were 3.1 min and 5.2 min respectively. Results: The correlation co-efficient for Paracetamol and Flupirtine Maleate were found to be 0.99 and 1 respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Paracetamol and Flupirtine Maleate in formulations was found to be 100% and 100% respectively confirms the non-interferences of the excipients in the formulation. Conclusion: Due to its simplicity, rapidness and high precision, this method was successfully applied to the estimation of Paracetamol and Flupirtine Maleate in combined dosage form.
Key words: Flupritine maleate, method development, paracetamol, RP-HPLC, stability indicating and validation.