Thursday , 26 April 2018

RP-HPLC Method Development and Validation for Simultaneous Estimation of Paracetmol and Flupirtine Maleate in Tablet Doses Form

K. Puspavathamma, V. Hari Baskar*, B. Prathap, Ramesh Dhani, P. Rameeza
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore, A.P, India

Abstract
A new method was established for simultaneous estimation of Paracetamol and Flupirtine maleate by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Paracetamol and Flupirtine maleate by using Symmetry C18 Agilent (250*4.6mm,5μ), flow rate was 0.8ml/min, mobile phase ratio was  OPA buffer pH3.0: methanol (65:35). detection wave length was 280nm. The instrument used was WATERS HPLC Auto Sampler, Separation module Aliance 2695, PDA Detector , Empower-software version-2. The retention times of Paracetamol and Flupirtine maleate were found to be 4.7 mins and 3.5 mins. The assay of Paracetamol and Flupirtine maleate was performed with tablets and the % assay was found to be 100.18 and 100.00 which shows that the method is useful for routine analysis. The linearity of Paracetamol and Flupirtine maleate was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show  precision 0.1 and 0.1 for Paracetamol and Flupirtine maleate which shows that the method is precise. The acceptance criteria of  precision is RSD should be not more than 2.0% and the  precision data for Paracetamol and Flupirtine maleate was found to be  0.62 and 0.19 . The accuracy limit is the percentage recovery should be in the range of 97 – 103.0%.  The total recovery was found to be 101.00% and 100.00% for Paracetamol and Flupirtine maleate. The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The acceptance criteria for LOD and LOQ is 3 and 10.The LOD and LOQ for Paracetamol  was found to be 4.724 and 3.356 and LOD and LOQ for Flupirtine maleate was found to be 4.724 and 3.555 The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions. 

Keywords: Paracetamol , Flupirtine maleate, HPLC

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