STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF ANTIHISTAMINE DRUG AZELASTINE

Autor: Pasha Ty, Shital Patel
Rok vydání: 2018
Předmět:
Zdroj: Asian Journal of Pharmaceutical and Clinical Research. 11:248
ISSN: 2455-3891
0974-2441
DOI: 10.22159/ajpcr.2018.v11i8.25506
Popis: Objective: The objective of this research was to develop a simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic method for estimation of azelastine hydrochloride (AZL) in nasal spray preparation.Methods: Chromatography was performed on a 250 mm×4.6 mm, 5-μm particle size, Waters Spherisorb CN column using (50:50 v/v) mixture of potassium dihydrogen phosphate buffer and acetonitrile as mobile phase. The detection was carried out at 290 nm and flow rate employed was 1.0 ml/min. The degradation of AZL was studied under different ICH recommended stress conditions.Results: The retention time was 4.34 min for AZL. Linearity was established in the concentration range of 5–120 μg/ml, with a correlation coefficient of 0.9996. Limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.81 μg/ml and 2.44 μg/ml, respectively. Percentage recovery was found between 99 and 102%. The values of percentage relative standard deviation (
Databáze: OpenAIRE