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

    Published on:31st Dec, 2014
    Journal of Young Pharmacists, 2015; 7(2):81-88
    Original Article | doi:10.5530/jyp.2015.2.5

    Mallikarjunarao Nagasarapu1, Gowrisankar Dananna2

    1Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India.

    2Department of Pharmaceutical Analysis & Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.


    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.

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