Validated sensitive spectrofluorimetric method for determination of antihistaminic drug azelastine HCl in pure form and in pharmaceutical dosage forms: application to stability study

Abstract

A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of azelastine HCl (AZL) in either its pure state or pharmaceutical dosage form. The proposed method was based on measuring the native fluorescence of the studied drug in 0.2 M H SO at λ = 364 nm after excitation at λ = 275 nm. Different experimental parameters were studied and optimized carefully to obtain the highest fluorescence intensity. The proposed method showed a linear dependence of the fluorescence intensity on drug concentration over a concentration range of 10-250 ng/mL, with a limit of detection of 1.52 ng/mL and limit of quantitation of 4.61 ng/mL. Moreover, the method was successfully applied to pharmaceutical preparations, with percent recovery values (± SD) of 99.96 (± 0.4) and 100.1 (± 0.52) for nasal spray and eye drops, respectively. The results were in good agreement with those obtained by the comparison method, as revealed by Student's t-test and the variance ratio F-test. The method was extended to study the stability of AZL under stress conditions, where the drug was exposed to neutral, acidic, alkaline, oxidative and photolytic degradation according to International Conference on Harmonization (ICH) guidelines. Copyright © 2016 John Wiley & Sons, Ltd.

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] .…”

Synchronous Fluorescence as a Green and Selective Method for the Simultaneous Determination of Cetirizine and Azelastine in Aqueous Humor

“…Using 4 mL 0.5 M perchloric acid and water as the diluting solvent 2. Perchloric acid is not a green reagent [ 18 ] SFS (proposed method) Pharmaceutical preparations and with AZE in aqueous humor 0.1–2.0 µg mL −1 0.043 µg mL −1 Using 1 mL 0.4 M H 2 SO 4 and water as the diluting solvent For azelastine HPLC–UV Pharmaceutical preparations 0.2–20 µg mL −1 0.021 µg mL −1 Acetonitrile: phosphate buffer pH 3.5 (32:68 v/v) [ 22 ] HPLC–UV Pharmaceutical preparations 6.25–50 µg mL −1 2.41 µg mL −1 Acetonitrile: phosphate buffer pH 4.5 (50:50 v/v) [ 23 ] Spectrofluorimetry Pharmaceutical preparations 10–250 ng mL −1 4.61 ng mL −1 Using 0.2 M H 2 SO 4 as the diluting solvent [ 33 ] Spectrofluorimetry (comparison method) Pharmaceutical preparations 0.1–1.5 µg mL −1 0.073 µg mL −1 Using water as the diluting solvent [ 34 ] Spectrofluorimetry Pharmaceutical preparations 2–40 µg mL −1 0.4845 µg mL −1 Using ethanol as the diluting solvent [ 35 ] …”

“…Both BP [ 5 ] and USP [ 7 ] recommended non aqueous potentiometric titration with perchloric acid for AZE assay. Many articles have been published for its assay as HPLC [ 22 – 26 ], HPTLC [ 27 , 28 ], capillary electrophoresis [ 29 ], electrochemical analysis [ 30 , 31 ], NMR [ 32 ], spectrofluorimetry [ 33 – 35 ] and spectrophotometry [ 36 – 38 ].…”

Quantitative proton nuclear magnetic resonance method for simultaneous analysis of fluticasone propionate and azelastine hydrochloride in nasal spray formulation

“…Reviewing the literature revealed that different analytical methods were established for determination of FLP and AZH either alone or in combination. These methods include: spectrophotometry [5][6][7][8][9][10][11][12], spectrofluorometry [13,14], electrochemical methods [15][16][17], TLC [18,19], HPLC [5,11,[20][21][22][23][24][25][26][27][28][29]] HPTLC [30][31][32], LC/MS/MS [33][34][35][36][37][38][39] and capillary electrophoresis [40,41]. It was found that only two spectrophotometric methods [42,43] and two HPLC methods [44,45] were reported for quantification of the binary mixture of FLP and AZH.…”