INTERNATIONAL JOURNAL OF PHARMACY AND BIOLOGICAL SCIENCE (IJPBS)
Published July 1, 2025 | Version v1
Journal article Open

Method Development and Validation for The Estimation of Zafirlukast in Bulk and Marketed Tablet Formulation by Using RP-HPLC Method

Authors/Creators

  • 1. Moonray Institute of Pharmaceutical Science, Raikal, Shadnagar, Rangareddy, Telangana

Contributors

  • 1. Moonray Institute of Pharmaceutical Science, Raikal, Shadnagar, Rangareddy, Telangana

Description

A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic
method has been developed for the validated of Zafirlukast in bulk as well as in marketed
pharmaceutical dosage form. This separation was performed on a Symmetry ODS C18
(4.6mm×250mm, 5µm) column with Methanol: Phosphate Buffer (40:60%) v/v as mobile phase
at a flow rate of 1.0 mL min−1 with UV detection at 235 nm; the constant column temperature
was Ambient. The run time under these chromatographic conditions was less than 8 min. The
retention time of Zafirlukast was found to be 2.293min. The calibration plot was linear over the
concentration range of 6–14 μg mL−1 with limits of detection and quantification values of 1.2
and 3.6 ng mL−1 respectively. The mean % assay of marketed formulation was found to be
99.86%, and % recovery was observed in the range of 98-102%. Relative standard deviation for
the precision study was found <2%. The developed method is simple, precise, specific, accurate
and rapid, making it suitable for estimation of Zafirlukast in bulk and marketed pharmaceutical
dosage form dosage form.

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Additional details

References

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