ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Degradation kinetics of Bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition

Radia Ouarezki, Saliha Guermouche, and Moulay-Hassane Guermouche

Faculté de chimie, Laboratoire de Chromatographie, USTHB, Algiers, Algeria

E-mail: radouarezki@gmail.com

Received: 2 July 2019  Accepted: 3 October 2019

Abstract:

Oxidative degradation of Bilastine has been investigated using hydrogen peroxide agent. An RP-HPLC assay method is developed and validated for quantitative determination of Bilastine in tablets. The chromatography is performed using Waters Symmetry C18 (250 mm length × 4.6 mm ID with 5 µm particle size) column, diode array detector (Waters 996) operating at 275 nm. Isocratic elution with mobile phase consisted of a mixture of acetonitrile and phosphate buffer (10 mM Na₂HPO₄ adjusted to pH with 5.5 with H₃PO₄) in the proportion 30:70 (v/v). The mobile phase is filtered and degassed in ultrasonic bath prior to use. Flow rate is fixed to 1.0 mL.min⁻¹. LC–ESI–MS/TOF, ¹H, and ¹³C NMR are used to characterize the degradation product resulting from oxidative stress conditions. Degradation kinetic of Bilastine oxidation was established and activation energy calculated. The developed HPLC method was validated after calculation of the current parameters (specificity, linearity, accuracy, precision, robustness, and stability). The proposed method can be used for routine determination of Bilastine in tablets.

Keywords: Bilastine; Oxidative degradation study; HPLC–DAD; ESI–MS/TOF; NMR

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-019-00956-x

Chemical Papers 74 (4) 1133–1142 (2020)