A STABILITY-INDICATING AND VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE AND FEXOFENADINE IN BULK AND TABLET DOSAGE FORMS

  • B.sai Kumar
  • Jyothi G
  • Sreenivasa Rao B

Abstract

ABSTRACT
Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated
for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.
Methods: Chromatography was carried out on an ODS C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of
orthophosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the
detection was carried out using a photodiode array detector at 210 nm.
Results: The retention times for phenylephrine and fexofenadine were 2.096 minutes and 4.241 minutes, respectively. The percentage recoveries
of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be
<2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine,
respectively.
Conclusion: Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing
both drugs in quality control laboratories and pharmaceutical industries.
Keywords: Phenylephrine, Fexofenadine, Stability indicating method, Validation method, Reversed-phase high performance liquid chromatography.

References

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How to Cite
Kumar, B., J. G, and S. Rao B. “A STABILITY-INDICATING AND VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE AND FEXOFENADINE IN BULK AND TABLET DOSAGE FORMS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 9, no. 8, Oct. 2016, pp. 144-8, doi:10.22159/ajpcr.2016.v9s2.13371.
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