Affiliation:
1. Beni-Suef University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Alshaheed Shehata Ahmad Hegazy St, Beni-Suef 62514, Egypt
2. University of Tabuk, Faculty of Pharmacy, Pharmaceutical Chemistry Department, Tabuk 71491, Kingdom of Saudi Arabia
3. National Organization for Drug Control and Research, 6 Abu Hazem St, Pyramids Ave, PO Box 29, Giza 12552, Egypt
4. Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St, Cairo 11562, Egypt
Abstract
Abstract
Validated simple, sensitive, and highly selective methods are applied for the quantitative determination ofdexamethasone and chlorpheniramine maleate in the presence of their reported preservatives (methylparaben and propylparaben), whether in pure forms or in pharmaceutical formulation. TLC is the first method, in which dexamethasone, chlorpheniramine maleate, methylparaben, and propylparaben are separated on silica gel TLC F254 plates using hexane–acetone–ammonia (5.5 + 4.5 + 0.5, v/v/v) as the developing phase. Separated bands are scanned at 254 nm over a concentration range of 0.1–1.7 and 0.4–2.8 μg/band, with mean ± SD recoveries of 99.12 ± 0.964 and 100.14 ± 0.962%, for dexamethasone and chlorpheniramine maleate, respectively. Reversed-phase HPLC is the second method, in which a mixture of dexamethasone and chlorpheniramine maleate, methylparaben, and propylparaben is separated on a reversed-phase silica C18 (5 μm particle size, 250 mm, 4.6 mm id) column using 0.1 M ammonium acetate buffer–acetonitrile (60 + 40, v/v, pH 3) as the mobile phase. The drugs were detected at 220 nm over a concentration range of 5–50 μg/mL, 2–90 μg/mL, 4–100 μg/mL, and 7–50μg/mL, with mean ± SD recoveries of 100.85 ± 0.905, 99.67 ± 1.281, 100.20 ± 0.906, and 99.81 ± 0.954%, for dexamethasone, chlorpheniramine maleate, methylparaben paraben, and propylparaben, respectively. The advantages of the suggested methods over previously reported methods are the ability to detect lower concentrations of the main drugs and to show better resolution of interfering preservatives; hence, these methods could be more reliable for routine QC analyses.
Publisher
Oxford University Press (OUP)
Subject
Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry