STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF ANTIHISTAMINE DRUG AZELASTINE
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2018, Vol 11, Issue 8
Abstract
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 (<2%) proved the high precision of the proposed method. The method was found to be robust regarding any small variation in the column temperature, pH of mobile phase, and mobile phase ratio. AZL was found stable in 5 M HCl at 80°C for 5 h, 5 M NaOH at 80°C for 5 h, 30% H2O2 at 80°C for 5 h, and in oven at 70°C for 8 h.Conclusion: The results obtained in this research work clearly proved that the proposed HPLC method for the assay of AZL in nasal spray preparation is simple, precise, specific, accurate, and stability indicating. It indicates that the method is suitable for analysis of AZL in the raw material and the pharmaceutical product without interference from excipients.
Authors and Affiliations
Shital Patel, Pasha Ty
Keywords
Related Articles
- EP ID EP567346
- DOI 10.22159/ajpcr.2018.v11i8.25506
- Views 151
- Downloads 0
CYTOMORPHOLOGICAL DETECTION OF MALIGNANT EFFUSIONS IN NON-HODGKIN LYMPHOMA: AN INSTITUTIONAL EXPERIENCE IN A DEVELOPING COUNTRY
Objective: Lymphomatous effusions of the body cavity may be the presenting feature or develop later as a complication of systemic disease. The detection rate of lymphoma in cytologic specimen is low, especially in the ab...
SANSEVIERIA HYACINTHOIDES (L.) DRUCE: A REVIEW OF ITS BOTANY, MEDICINAL USES, PHYTOCHEMISTRY, AND BIOLOGICAL ACTIVITIES
Sansevieria hyacinthoides is a succulent perennial herb widely used as herbal medicine. This study is aimed at providing a critical review of the botany, biological activities, phytochemistry, and medicinal uses of S. hy...
COMPARATIVE ANALYSIS OF THE ANTICANCER ACTIVITY OF ANGIOTENSIN RECEPTOR BLOCKERS - IRBESARTAN AND TELMISARTAN
Objective: Angiotensin receptor blockers (ARBs) are effective hypertensive drugs. Reduction in risk of lung cancer with ARBs was proven in clinical studies. Telmisartan and irbesartan are the second-generation ARBs. This...
ANTIOXIDANT ACTIVITIES AND TOTAL PHENOLIC AND FLAVONOID CONTENT VARIATIONS OF LEAF EXTRACTS OF LAURUS NOBILIS L. FROM MOROCCO
Objective: The present study was undertaken to determine antioxidant activity and total phenolic and flavonoid content of ethanol, methanol, ethyl acetate, and aqueous extracts of the leaves of Laurus nobilis L.Methods:...
FORMULATION DEVELOPMENT AND EVALUATION OF PRONIOSOMAL GEL OF ETHINYLESTRADIOL AND LEVONORGESTREL FOR ANTIFERTILITY TREATMENT
Objective: The purpose of this research was to develop and formulate proniosomal gel drug delivery system of ethinylestradiol and levonorgestrel for antifertility treatment that is capable of efficiently delivering entra...