Improvement in Quality Control Methods for Belladonna Oral Solution / 中国药师

ABSTRACT

Objective:To improve the identification and determination methods in the original quality standard for belladonna oral solution.Methods:Belladonna oral solution was identified by a specific chromatogram of HPLC,and scopoletin and hyoscyamine sulfate in belladonna oral solution were detected by dual wavelength spectrophotometry.The detection of fingerprints was performed on a Waters SunFire C18 (250 mm×4.6mm,5 μm) column.The mobile phase was methanol-0.05% phosphoric acid solution at a flow rate of 1.0 ml·min-1.The detection wavelength was 344 nm and the column temperature was 30℃.The detection of scopoletin and hyoscyamine sulfate was performed on the same C18 column.The mobile phase was 10 mmol·L-1 heptanesulfonate sodiumat (pH value was 3.3 adjusted by glacial acetic acid)-absolute ethanol-acetonitrile (68.75∶6.25∶25) at a flow rate of 1.0 ml·min-1.The detection wavelengths were 344 nm and 210 nm,and the column temperature was 30℃.Results:The specific chromatogram of belladonna oral solution was accordance with that of belladonna tincture raw material.The retention time and relative peak area of each characteristic peak and reference peak all met requirements of Chinese Pharmacopoeia.Scopoletin and hyoscyamine sulfate were completely separated from the other compositions under the above mentioned conditions.The calibration curves were linear within the range of 5.168-103.360 μg·ml-1 (r=1.000 0) for scopoletin and 50.560-758.400 μg·ml-1 (r=0.999 9) for hyoscyamine sulfate.The average recovery was 101.79% (RSD=1.05%,n=6) and 100.92% (RSD=0.97%,n=6),respectively.Conclusion:After the quality control method improvement,the identification shows high specificity and the quality of belladonna oral solution can be better controlled by the two selected index components.The method is easy and accurate,which can provide a reliable way to control the quality.