A New Sensitive Isocratic RP-HPLC Method Development and Validation for Simultaneous Estimation of Fexofenadine Hydrochloride, Paracetamol and Phenylephrine Hydrochloride in Fixed Dose Tablet

Abstract

Introduction: The purpose of this research project is to develop and validate a new simple, rapid and sensitive RP-HPLC method for Simultaneous Quantification of Fexofenadine Hydrochloride, Paracetamol and Phenylephrine Hydrochloride in fixed dose Tablet.Materials and Methods: The three analytes are separated by HPLC using an X-bridge Shield column (250 × 4.6 mmID, 5 µm) as the stationary phase and a moving phase that contains Orthophosphoric Acid (0.1%), pH was maintained to 6.0 with sodium hydroxide and acetonitrile in a 65:35 ratio. The HPLC analysis were carried out at flow rate of 1 mL min-1, column oven temperature 35ºC at peak detection of 220nm with Photo diode array Detector. The analytical approach developed in this study was validated as per ICH recommendations.Results: These optimized RP-HPLC method shows excellent linearity between 24 to 36 µg/mL for Fexofenadine Hydrochloride, 4 to 6 µg/mL for phenylephrine hydrochloride and 128-192 µg/mL for Paracetamol and correlation coefficient were determined as 0.9998, 0.9994 and 0.9990 respectively. The precision of six repeated measurements RSD did not exceed 2%.Conclusion: The optimized RP-HPLC method demonstrated Linearity, accuracy, precision, specificity and Robustness for Simultaneous Quantitative estimation within short duration of time.

Keywords: Fexofenadine Hydrochloride (FEH); Paracetamol (PARA); Phenylephrine Hydrochloride (PEH); RP-High Performance Liquid Chromatography; Method Validation