Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Paracetamol and Flupirtine maleate in Pure and Pharmaceutical Dosage Forms

Abstract

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 combineddosage form.Materials and Methods: A Hypersil BDS C18, 150 x 4.6, 5 μ column 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 noninterferences of the excipients in the formulation. Degradation studies reveals that purity threshold is greater than the purity angle hence the peak is said to be pure.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.

Keywords: Flupritine maleate; method development; paracetamol; RP-HPLC; stability indicating and validation.