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.

A simple stability-indicating HPLC method for simultaneous analysis of paracetamol and caffeine and its application to determinations in fixed-dose combination tablet dosage form

“…Specificity. Specificity of an ideal analytical method is its ability to detect the analytes in the presence of other constituents such as products of degradation, impurities, and excipients that are expected to be present [28]. The specificity of the proposed method was determined by subjecting the standard and test sample solutions to forced degradation by acidic and alkaline hydrolysis, oxidative, photolytic, and thermal stress.…”