Efficient UPLC and CE methods for the simultaneous determination of azelastine hydrochloride and its genotoxic impurity

Abstract

A novel stability-indicating UPLC and CE method was established and validated for the determination of azelastine hydrochloride (AZL) and its genotoxic impurity, benzohydrazide, in the presence of benzalkonium chloride. The developed UPLC method was based on chromatographic separation using a C column as a stationary phase and acetonitrile-(0.1% w/v) aqueous sodium lauryl sulfate (55:45, v/v, pH 5 with phosphoric acid) as a mobile phase with a flow rate of 1.2 mL/min and UV detection at 215 nm. The chromatographic run time was ~2 min. The developed CE method depended on using a stationary phase of Standard Bare Fused Silica Capillaries (75 μm i.d. × 59 cm and 50 cm detection length) and the applied voltage was 30 kV using 40 mm phosphate buffer (pH 2 with aqueous H PO ); the detection wavelength was 225 nm. The analysis time was about 6 min. The suggested methods were successfully applied for the analysis of AZL in a pharmaceutical preparation. The validity of the developed methods was assessed by applying the standard addition technique and no interference from excipients was observed. The results obtained by the proposed methods were statistically analyzed and compared with the manufacturer's method and no significant difference was found between the compared methods.

Factorial design-assisted reverse phase HPLC–UV approach for the concurrent estimation of cetirizine and azelastine in aqueous humor

“…Different articles have been reported in the literature for the determination of AZE either in dosage form, human plasma or aqueous humor. These articles include: HPLC [27][28][29][30][31] , HPTLC 32,33 , capillary electrophoresis 34 , electrochemical analysis 35,36 , NMR 37 , spectrofluorimetry 22,[38][39][40] and spectrophotometry [41][42][43] .…”

Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review

“…A list of CZE‐UV methods applicable to quality control analyses of pharmaceuticals published during the last 5 years is provided in Table 1 [30–52]. Such a typical procedure was introduced by Mufusama et al [33].…”

“…Abdelwahab et al reported a comparison of UHPLC‐ and CE‐based methods for quality control of an antihistamine azelastine and determination of both a genotoxic impurity benzohydrazine and benzalkonium chloride (C12; C14) which is commonly used as a preservative in pharmaceutical formulations; however, may be harmful in higher concentrations [34]. The CE method enabling baseline separation of all the analytes in less than 6 min showed comparable values of validation parameters, as well as results of Azelast ® eye drops analyses, with the presented UHPLC procedure.…”

Synthesis, characterization and cell selectivity of poly(quaternary ammonium chlorides): effect of the degree of quaternization and copolymer composition

“…[35][36][37][38] Historically, (co)polymers of vinyl benzyl chloride have been used in Merrifield resins that are part of solid phase synthesis, in gas chromatography, phase transfer catalysis and many other applications. [39][40][41][42][43][44][45][46] To the best of our knowledge, there is no report detailing the facile preparation of poly(vinyl quaternary ammonium chloride)s with varying quaternary ammonium species starting from 4-vinyl benzyl chloride, except for two reports that contain specific derivatives such as poly(vinyl benzyl trimethylammonium chloride) and 4-vinyl benzyl dimethylhexadecylammonium chloride. [47][48][49] Considering that benzalkyl ammonium chlorides are widely used 50 as disinfectants, ophthalmic preservatives and antiseptics, quaternary ammonium polymers obtained by the quaternization of homo-and copoly(4-vinyl benzyl chloride) can be potentially used as antimicrobial agents.…”