A New Sensitive Isocratic RP-HPLC Method Development and Validation for Simultaneous Estimation of Fexofenadine Hydrochloride, Paracetamol and Phenylephrine Hydrochloride in Fixed Dose Tablet
1, 2
- 1Department of Pharmaceutical Chemistry, The Oxford College of Pharmacy, Bangalore, Karnataka, INDIA.
- 2Department of Pharmaceutical Analysis, Institute of Pharmacy, PES University, Bangalore, Karnataka, INDIA.
CORRESPONDENCE
Vanisha Chitti Babu
Department of Pharmaceutical Chemistry, The Oxford College of Pharmacy, Bangalore, Karnataka, INDIA.
Volume 60, Issue 5 (KrupaPharmaCon 2026) · pp. 232-244 · 2026 · DOI: 10.5530/ijper.krupapharmacon.40
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.
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Babu, V. C., & Patra, B. R. (2026). A New Sensitive Isocratic RP-HPLC Method Development and Validation for Simultaneous Estimation of Fexofenadine Hydrochloride, Paracetamol and Phenylephrine Hydrochloride in Fixed Dose Tablet. Indian Journal of Pharmaceutical Education and Research, 60(5), 232-244. https://doi.org/10.5530/ijper.krupapharmacon.40
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