Simultaneous Quantifi cation of Chlorpheniramine, Pseudoephedrine, and Ibuprofen in Antitussive Preparation by High-Performance Liquid Chromatography and Thin-Layer Chromatography--Densitometric Methods.

Simple, accurate, precise, sensitive, and validated high-performance liquid chromatography (HPLC) and thin-layer chromatography (TLC)--densitometric methods were developed for the simultaneous determination of chlorpheniramine maleate (CPM), pseudoephedrine HCl (PSE), and ibuprofen (IBF) in tablet dosage form. In method A, reversed-phase (RP)-HPLC analysis was performed on Zorbax C₈ column (150 mm x 4.6 mm, 5 μm particle size i.d.), using a mobile phase consisting of methanol--acetonitrile--distilled water (pH 4) using orthophosphoric acid in the ratio (80:10:10, v/v) and fl ow rate of 0.7 mL min^-1. Quantifi cation was achieved with ultraviolet (UV) detection at 220 nm. In method B, TLC analysis was carried out on an aluminum-backed sheet of silica gel 60 F₂₅₄ layer using ethyl acetate--methanol--ammonia (8:2:0.8, v/v) as the mobile phase. Quantifi cation was carried out with UV detection at 262 nm. The validation of the proposed methods was applied according to the International Conference on Harmonization (ICH) guidelines. The suggested methods were successfully applied for the determination of the cited drugs in bulk powder and commercial dosage form. [ABSTRACT FROM AUTHOR]