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Simultaneous Determination of Two Components in Diphenhydramine and Ephedrine Nasal Drops by HPLC

Gao Shan, Tang Lei, Weiguo Zhao

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Abstract

OBJECTIVE To establish a method for simultaneous content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in the nasal drops by HPLC. METHODS The chromatographic conditions included the Eclipse XDBC18column( 250 mm×4. 6 mm,5 μm) and methanol-0.05 mol / L potassium dihydrogen phosphate( the p H was adjusted 3.0 with 85%phosphoric acid)-trimethylamine( 52 ∶ 48 ∶ 0. 2) as the mobile phase. The flow rate was 1. 0 m L / min and monitored at 257 nm.RESULTS The concentration of ephedrine hydrochloride in 2.025 8-6.077 4 mg / m L was linear. The average recovery and RSD were99.96% and 0.43%,respectively( n = 9). The linear range of diphenhydramine hydrochloride was 0.201 4-0.604 2 mg / m L. The average recovery rate was 100.14% with RSD 0. 58%( n = 9). CONCLUSION This method is fast and reproducible. It can be used as a reliable method for quality control of Diphenhydramine and Ephedrine Nasal drops.

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OBJECTIVE To establish a method for simultaneous content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in the nasal drops by HPLC. METHODS The chromatographic conditions included the Eclipse XDBC18column( 250 mm×4. 6 mm,5 μm) and methanol-0.05 mol / L potassium dihydrogen phosphate( the p H was adjusted 3.0 with 85%phosphoric acid)-trimethylamine( 52 ∶ 48 ∶ 0. 2) as the mobile phase. The flow rate was 1. 0 m L / min and monitored at 257 nm.RESULTS The concentration of ephedrine hydrochloride in 2.025 8-6.077 4 mg / m L was linear. The average recovery and RSD were99.96% and 0.43%,respectively( n = 9). The linear range of diphenhydramine hydrochloride was 0.201 4-0.604 2 mg / m L. The average recovery rate was 100.14% with RSD 0. 58%( n = 9). CONCLUSION This method is fast and reproducible. It can be used as a reliable method for quality control of Diphenhydramine and Ephedrine Nasal drops.

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Available abstract

OBJECTIVE To establish a method for simultaneous content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in the nasal drops by HPLC. METHODS The chromatographic conditions included the Eclipse XDBC18column( 250 mm×4. 6 mm,5 μm) and methanol-0.05 mol / L potassium dihydrogen phosphate( the p H was adjusted 3.0 with 85%phosphoric acid)-trimethylamine( 52 ∶ 48 ∶ 0. 2) as the mobile phase. The flow rate was 1. 0 m L / min and monitored at 257 nm.RESULTS The concentration of ephedrine hydrochloride in 2.025 8-6.077 4 mg / m L was linear. The average recovery and RSD were99.96% and 0.43%,respectively( n = 9). The linear range of diphenhydramine hydrochloride was 0.201 4-0.604 2 mg / m L. The average recovery rate was 100.14% with RSD 0. 58%( n = 9). CONCLUSION This method is fast and reproducible. It can be used as a reliable method for quality control of Diphenhydramine and Ephedrine Nasal drops.

Key concepts: Diphenhydramine hydrochloride, Chromatography, Diphenhydramine, Chemistry, High-performance liquid chromatography, Ephedrine, Phosphoric acid, Potassium

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