RESUMO
OBJECTIVE:To establish a method for simultaneous determination of ephedrine hydrochloride,nitrofural and di-phenhydramine hydrochloride in Compound diphenhydramine nasal drop. METHODS:RP-HPLC method was adopted. The determi-nation was performed on Inertsil ODS-3 C18 column with mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate buf-fer(pH 7.0)-acetonitrile(gradient elution)with flow rate of 1.0 mL/min. The detection wavelength was set at 256 nm,and the col-umn temperature was 35 ℃. The sample size was 20 μL. RESULTS:The concentrations of phedrine hydrochloride,nitrofural and diphenhydramine hydrochloride ranged 122.1-366.3 μg/mL(r=0.9999),5.2-15.5 μg/mL(r=0.9998)and 31.5-94.5 μg/mL(r=0.9994),respectively. The limits of quantitation were 2.442,0.010,2.520 μg/mL,and the limits of detection were 0.810,0.003, 0.830 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 1.0%. The recoveries of them were 99.2%-101.7%(RSD=0.9%,n=9),96.4%-102.0%%(RSD=1.7%,n=9),100.2%-101.9%(RSD=0.4%,n=9),respec-tively. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for simultaneous determination of ephedrine hydrochloride,nitrofural and diphenhydramine hydrochloride in Compound diphenhydramine nasal drop.
RESUMO
Objective: To establish the quality standard for Yuhuang sprays. Methods: Berberine hydrochloride in Yuhuang sprays was qualitatively identified by TLC and determined by UV. The Vanillin-H2 SO4 method was employed for the determination of condensed tannins. Results:The spots obtained from the sample solutions showed the same color as those from the reference substance solution without interference from the negative sample. The calibration curve of berberiny hydrochloride was linear within the range of 1. 13-13. 60μg·ml-1(r=0. 999 9), and the average recovery was 99. 68% with RSD of 1. 53%(n=9). The calibration of catechin was linear within the range of 0. 03-0. 30 mg· ml-1(r=0. 999 3), and the average recovery was 99. 6% with RSD of 1. 76%(n=9). Conclusion:The method can be used in the quality control of Yuhuang sprays.