Validated spectroscopic methods for determination of anti-histaminic drug azelastine in pure form: Analytical application for quality control of its pharmaceutical preparations

• Published in: Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy Vol. 191; pp. 413 - 420
• Main Authors: El-Masry, Amal A., Hammouda, Mohammed E.A., El-Wasseef, Dalia R., El-Ashry, Saadia M.
• Format: Journal Article
• Language: English
• Published: England Elsevier B.V 15.02.2018
• Subjects: Azelastine HCl (AZL); Binary complex; Difference spectroscopy; Eosin; Spectral difference; Spectral difference; Azelastine HCl (AZL); Binary complex; Difference spectroscopy; Eosin
• ISSN: 1386-1425; 1873-3557
• DOI: 10.1016/j.saa.2017.10.049

Two simple, sensitive, rapid, validated and cost effective spectroscopic methods were established for quantification of antihistaminic drug azelastine (AZL) in bulk powder as well as in pharmaceutical dosage forms. In the first method (A) the absorbance difference between acidic and basic solutions was measured at 228nm, whereas in the second investigated method (B) the binary complex formed between AZL and Eosin Y in acetate buffer solution (pH3) was measured at 550nm. Different criteria that have critical influence on the intensity of absorption were deeply studied and optimized so as to achieve the highest absorption. The proposed methods obeyed Beer's low in the concentration range of (2.0–20.0μg·mL−1) and (0.5–15.0μg·mL−1) with % recovery±S.D. of (99.84±0.87), (100.02±0.78) for methods (A) and (B), respectively. Furthermore, the proposed methods were easily applied for quality control of pharmaceutical preparations without any conflict with its co-formulated additives, and the analytical results were compatible with those obtained by the comparison one with no significant difference as insured by student's t-test and the variance ratio F-test. Validation of the proposed methods was performed according the ICH guidelines in terms of linearity, limit of quantification, limit of detection, accuracy, precision and specificity, where the analytical results were persuasive. The absorption spectra of AZL, where(a)The absorption spectrum of AZL (16μg·mL−1) in 0.1M HCl.(b)The absorption spectrum of AZL (16μg·mL−1) in 0.1M NaOH.(c)The difference absorption spectrum of AZL (16μg·mL−1) in 0.1M NaOH vs 0.1M HCl.(d)The absorption spectrum of eosin binary complex with AZL (10μg·mL−1). [Display omitted] •Validated spectroscopic methods for determination of anti-histaminic drug azelastine in pure form with analytical application for quality control of its pharmaceutical preparations.•Two methods was adopted, In the first method (A) the absorbance difference between acidic and basic solutions was measured at 228 nm, whereas in the second investigated method (B) the binary complex formed between AZL and Eosin Y in acetate buffer solution (pH 3) was measured at 550 nm.•The proposed spectroscopic methods were simple, sensitive, rapid and cost effective methods.•The proposed methods were easily applied for quality control of pharmaceutical preparations without any conflict with its co-formulated additives,