Abstract
DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF ZAFIRLUKAST IN TABLET DOSAGE FORM

Kajal S. Khadke* and Ruchika S. Chavan

ABSTRACT

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Zafirlukast in tablet dosage form. Methods: The drug is freely soluble in analytical grade acetonitrile.[1] The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics.[2] It showed absorption maxima were determined in acetonitrile: water (80:20, v/v). The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity.[3,4,5,6] The UV spectroscopic method was developed for estimation of Zafirlukast in tablet dosage form and also validated as per ICH guidelines.[7] Results: The drug is freely soluble in tetrahadyofuran, acetonitrile and acetone. Slightly soluble in methanol and practically insoluble in water. So, the analytical grade acetonitrile: water (80:20, v/v) is used as a diluent in method. The melting point of Zafirlukast was found to be 139-140˚C (uncorrected). It showed absorption maxima 270 nm in analytical grade acetonitrile. On the basis of absorption spectrum the working concentration was set on 10μg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.0 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.36%. Conclusion: A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Zafirlukast in tablet dosage form. The method could be considered for the determination of Zafirlukast in quality control laboratories.

Keywords: Zafirlukast, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.


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