Degradation Product of Preservatives in Buserelin Injection by HPLC
To establish a high-performance liquid chromatography(HPLC)method for the determination of benzaldehyde,a degradation product of benzyl alcohol,in buserelin injection as a preservative.The column was ODS-2 Hypersil column(4.6 mm × 250 mm,5 μm).The mobile phase was phosphate buffer(11.2 g·L-1 phosphate acid solution,pH value was adjusted to 2.5 with triethylamine)-acetonitrile(77:23).The flow rate was 1.0 mL·min-1.The detection wavelength was 220 nm.The column temperature was 40 ℃ and injection volume was 100 μL.Under the chromatographic conditions,the content of benzaldehyde in each batch of samples was less than 10 μg·mL-1,the concentration of benzaldehyde had a good linear relationship with peak area in the range of 1.010～14.140 μg·mL-1(r=0.9996),the detection limit is 3 ng·mL-1 and the quantification limit is 10 ng·mL-1,and the average recovery rate was 101.82％.The method was accurate,reproducible,and can be used for the determination of benzaldehyde in Busherelin injection.
万方数据
维普
