ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ZOFIRLUKAST IN FORMULATION BY RP-HPLC
B. Roopa Rani*, Dr. Ch. M. M. Pradada Rao, D. Dhachinamoorthi
ABSTRACT
A new gradient reverse Phase High Performance Liquid chromatographic method development for the determination of Zofirlukast tablet dosage form. The chromatographic separation was achieved on a Thermo Zorbax SB C8,150×4.6mm,5?, column within a runtime of 6.074 min under gradient elution by a mixture of buffer and acetonitrile and water at at 75:25 at flow rate of 0.8ml/min. A photodiode array (PDA) detector set at 238 nm was used for detection. The spectrophtometric method was developed for the Zofirlukast at uv cut of range of 200-400nm here the absorption max was shown at 238 nm. The method was validated according to the ICH guidelines with respect to specificity, precision, accuracy and linearity, and showing satisfactory data for all the method validation parameters tested. The % RSD for peak area response was found to be within the limit. The proposed method was found to be reproducible and convenient for the analysis of Zofirlukast, the method can be used for routine quality control analysis
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