Simultaneous determination of Fluticasone propionate and Azelastine hydrochloride in the presence of pharmaceutical dosage form additives

Citation:
Merey, H. A., S. S. El-Mosallamy, N. Y. Hassan, and B. A. El-Zeany, "Simultaneous determination of Fluticasone propionate and Azelastine hydrochloride in the presence of pharmaceutical dosage form additives", Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, vol. 160, pp. 50-57, 2016.

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 5.00–80.00 μg/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.

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