Author(s): Hinuja Miriyala, Narender Addu, Jwala Srinivasa Phani Krishna Darsi and Sunder Kumar Kolli

Abstract: A simple and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of intermediates formed during the synthesis of Bilastine drug via 2-[4-(2-Chloro-ethyl)-phenyl]-2-methyl-propionic Acid Methyl Ester route has been developed. The intermediates formed during the 2-step synthesis of Bilastine have been separated on a Kromasil C18: (250 x 4.6mm,5um)or its equivalent with isocratic elution using 1% ammonium acetate and acetonitrile 95:05 v/v as mobile phase, with flow rate of 1.0 mL/min and detected at 220 nm using Photo Diode Array (PDA). The developed method was validated for accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ) and ruggedness. The correlation coefficients for calibration curves of intermediates were in the range of 0.995-0.999. The proposed reverse-phase HPLC method was successfully applied for the estimation of intermediates=impurities present in Bilastine bulk drug; the recoveries of intermediates were in the range of 97.32-99.56% and precision values were less than 3%. The method was found to be specific, precise, and reliable for the determination of intermediates and synthetic impurities in the Active Pharmaceutical Ingredient (API) of Bilastine.

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