Abstract

AbstractRapid, isocratic, and sensitive micellar liquid chromatographic methods were developed successfully for the analysis of two ternary mixtures: phenylephrine hydrochloride (PHE), ibuprofen (IBU) and chlorpheniramine maleate (CP) (mixture I), and pseudoephedrine hydrochloride (PSE), IBU and CP (mixture II) in their synthetic mixtures and pharmaceutical dosage forms. Analytical separation was achieved in 7 min using monolithic column adopting UV detector at 233 and 218 nm for mixture I and II, respectively. For both mixtures, a micellar mobile phase solution composed of 0.15 M sodium dodecyl sulphate, 15% n‐propanol, and 0.3% triethylamine adjusted to pH 4.0 by 0.02 M phosphoric acid was utilized applying a flow rate of 1.2 ml/min. The methods were fully validated in accordance with the International Conference on Harmonization guidelines. The proposed methods were linear in the range of 0.5–20.0 μg/ml for PHE and 10.0–400.0 μg/ml for IBU, and CP 0.25–8.0 μg/ml (mixture I) and in the range of 3.0–60.0 μg/ml for PSE and 20.0–400.0 μg/ml for IBU, and CP 0.2–4.0 μg/ml (mixture II) and methanol was utilized as diluting solvent. Furthermore, the proposed methods exhibited good accuracy and repeatability (R.S.D. < 2.0%). The limits of detection were 0.07 (PHE), 1.85 (IBU), 0.04 (CP) for mixture I and were 0.41 (PSE), 2.37 (IBU), 0.02 (CP) for mixture II. The limits of quantitation were 0.22 (PHE), 5.61 (IBU), 0.12 (CP) for mixture I and were 1.24 (PSE), 7.17 (IBU), 0.07 (CP) for mixture II, respectively. The new chromatographic method could successfully substitute traditional hazardous liquid chromatographic methods for the separation of the provided polar compounds consuming lower percent of environmentally toxic organic solvents.

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