Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BILASTINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UPLC
Shaista Firdous* and S. H. Rizwan
ABSTRACT
This paper describes a new validated Ultra Performance Liquid Chromatography (HPLC) method for the determination of Bilastine in bulk and pharmaceutical dosage form. The objective of the study is to develop a rapid, precise, accurate, robust UPLC method for the determination of Bilastine with acceptable retention time. The mobile phase consists of pH 3.5 Sodium Phosphate 10mM Buffer : Methanol : Acetonitrile (60 : 30 : 10 v/v/v), at a flow rate of 0.5 ml/min, with a PDA detector at 248 nm. Separation was achieved on a Phenomenex C8 column (1.7 μm; 50 mm × 2.1 mm ID) maintained at 30 °C temperature in a column oven. The method was linear between 50μg/mL – 150μg/mL concentration range. The limit of detection was 0.368μg/mL and the limit of quantification was 1.117μg/mL. The developed UPLC method achieved good precision and accuracy; suitable to be used for routine analysis of Bilastine.
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