title: Simultaneous determination of Fluticasone propionate and Azelastine hydrochloride in the presence of pharmaceutical dosage form additives.
abstract: Fluticasone propionate (FLU) and Azelastine hydrochloride (AZE) are co-formulated with phenylethyl alcohol (PEA) and Benzalkonium chloride (BENZ) (as preservatives) in pharmaceutical dosage form for treatment of seasonal allergies. Different spectrophotometric methods were used for the simultaneous determination of cited drugs in the dosage form. Direct spectrophotometric method was used for determining of AZE, while Derivative of double divisor of ratio spectra (DD-RS), Ratio subtraction coupled with ratio difference method (RS-RD) and Mean centering of the ratio spectra (MCR) are used for the determination of FLU. The linearity of the proposed methods was investigated in the range of 5.00-40.00 and 5.00-80.00μg/mL for FLU and AZE, respectively. The specificity of the developed methods was investigated by analyzing laboratory prepared mixtures containing different ratios of cited drugs in addition to PEA and their pharmaceutical dosage form. The validity of the proposed methods was assessed using the standard addition technique. The obtained results were statistically compared with those obtained by official or the reported method for FLU or AZE, respectively showing no significant difference with respect to accuracy and precision at p=0.05.
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El Aini Post, 11562 Cairo, Egypt.
authors.forename: Hanan A
authors.initials: HA
authors.lastname: Merey
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El Aini Post, 11562 Cairo, Egypt. Electronic address: sally_elmosalamy@hotmail.com.
authors.forename: Sally S
authors.initials: SS
authors.lastname: El-Mosallamy
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El Aini Post, 11562 Cairo, Egypt.
authors.forename: Nagiba Y
authors.initials: NY
authors.lastname: Hassan
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El Aini Post, 11562 Cairo, Egypt.
authors.forename: Badr A
authors.initials: BA
authors.lastname: El-Zeany
mesh_terms: D004304:Dosage Forms; D000068298:Fluticasone / Q000032:analysis* / Q000737:chemistry; D010626:Phenylethyl Alcohol / Q000737:chemistry; D010793:Phthalazines / Q000032:analysis* / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D013053:Spectrophotometry
chemical_list: D004304:Dosage Forms; D010793:Phthalazines; D000068298:Fluticasone; D010626:Phenylethyl Alcohol; C020976:azelastine
keywords: Azelastine hydrochloride; Derivative of double divisor of ratio spectra; Direct spectrophotometry; Fluticasone propionate; Mean centering