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Home Articles Vol 30,2026 No.9 Detail

Simultaneous determination of principal component and disodium edetate in azelastine hydrochloride nasal spray by dual-wavelength HPLC

Published on Oct. 01, 2026Total Views: 644 times Total Downloads: 195 times Download Mobile

Author: LUO Xiaolei 1, 2 LI Yitong 3 QIN Li 1, 2

Affiliation: 1.Yunnan Institute for Food and Drug Control, Kunming 650106, China 2.Industrial Technology Basic Public Service Platform of the Ministry of Industry and Information Technology, Kunming 650106, China 3.China Pharmaceutical University School of Traditional Chinese Pharmacy, Nanjing 211198, China

Keywords: HPLC Nasal spray Azelastine hydrochloride Disodium edetate Content determination

DOI: 10.12173/j.issn.2097-4922.202606092

Reference: LUO Xiaolei,LI Yitong,QIN Li. Simultaneous determination of principal component and disodium edetate in azelastine hydrochloride nasal spray by dual-wavelength HPLC[J]. Frontiers in Pharmaceutical Sciences,2026,30(9):1532-1537. DOI:10.12173/j.issn.2097-4922.202606092[Article in Chinese]

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Abstract

Objective To establish a dual-wavelength HPLC method with pre-column derivatization for the determination of azelastine hydrochloride and disodium edetate in azelastine hydrochloride nasal spray.

Methods The chromatographic column was Waters XTerra RP18 column (150 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-acetic acid-sodium acetate buffer (pH 4.5) containing 10 mmol/L tetrabutylammonium bromide, and gradient elution was employed. The column temperature was set at 30 ℃. The detection wavelengths were set at 289 nm for azelastine hydrochloride and 254 nm for disodium edetate. The flow rate was 1.0 mL/min and injection volume was 20 µL.

Results Good linear relationships between the concentration and peak area were obtained for azelastine hydrochloride and disodium edetate over the ranges of 10.11-202.19μg/mL and 5.47-109.53 μg/mL, respectively (r ≥ 0.999 9). The average recoveries were 99.3% and 99.7%, respectively, with all RSD values less than 0.8% (n=9). The limits of quantitation were 0.40 μg/mL and 0.22 μg/mL for the two analytes, respectively. The RSD values of precision, stability and repeatability tests were all lower than 2.0% (n=6).

Conclusion This method is simple to operate and shows good repeatability and accuracy; it can be used for the simultaneous determination of azelastine hydrochloride and disodium edetate in azelastine hydrochloride nasal spray.

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