Background:
The first highly sensitive, rapid and specific green microemulsion liquid
chromatographic (MELC) method was established for the simultaneous estimation of fluticasone propionate
(FLU) and azelastine HCl (AZL) in the presence of their pharmaceutical dosage form additives
(phenylethyl alcohol (PEA) and benzalkonium chloride (BNZ)).
Methods:
The separation was performed on a C18 column using (o/w) microemulsion as a mobile
phase which contains 0.2 M sodium dodecyl sulphate (SDS) as surfactant, 10% butanol as cosurfactant,
1% n-octanol as internal phase and 0.3% triethylamine (TEA) adjusted at pH 6 by 0.02 M
phosphoric acid; with UV detection at 220 nm and programmed with flow rate of 1 mL/min.
Results:
The validation characteristics e.g. linearity, lower limit of quantification (LOQ), lower limit
of detection (LOD), accuracy, precision, robustness and specificity were investigated. The proposed
method showed linearity over the concentration range of (0.5-25 µg/mL) and (0.1-25 µg/mL) for FLU
and AZL, respectively. Besides that, the method was adopted in a short chromatographic run with satisfactory
resolution factors of (2.39, 3.78 and 6.74 between PEA/FLU, FLU/AZL and AZL/BNZ), respectively.
The performed method was efficiently applied to pharmaceutical nasal spray with (mean
recoveries ± SD) (99.80 ± 0.97) and (100.26 ± 0.96) for FLU and AZL, respectively.
Conclusion:
The suggested method was based on simultaneous determination of FLU and AZL in the
presence of PEA and BNZ in pure form, laboratory synthetic mixture and its combined pharmaceutical
dosage form using green MELC technique with UV detection. The proposed method appeared to
be superior to the reported ones of being more sensitive and specific, as well as the separation was
achieved with good performance in a relatively short analysis time (less than 7.5 min). Highly acceptable
values of LOD and % RSD make this method superior to be used in quality control laboratories
with of HPLC technique.