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Kinetic Spectrophotometric Determination of Zafirlukast in Bulk and in Drug Formulations

Simple, accurate and reliable kinetic spectrophotometric method was developed for the determination of zafirlukast (ZAF) in bulk powder and in pharmaceutical formulation. The proposed method depends on hydrolysis of zafirlukast using 1M NaOH at 100°C for 2.5 hours and subsequent reaction of the formed degradation product which contains primary amino (NH2-) group with 4-Chloro-7-nitrobenzo-2-oxa-1,3 diazole (NBD-Cl) at 90 ± 5 oC to form a yellow colored chromogen. The formed color is spectrophotometrically measured after 10 min at 466 nm. The fixed time method was adopted for constructing the calibration curve. The linearity range was found to be 0.5-3 μg mL -1, and the limit of detection is 0.139 μg mL -1 . The proposed method has been successfully applied to the determination of hydrolyzed zafirlukast in pharmaceutical dosage forms with no interference from the excipients. Statistical comparison of the results shows that there is no significant difference between the proposed and official methods. (Amal Mahmoud Abou Al Alamein. Kinetic Spectrophotometric Determination of Zafirlukast in Bulk and in