ABSTRACT
OBJECTIVE:To establish a method for the simultaneous determination of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen in Yaotong capsules.METHODS:HPLC method was adopted.The determination was performed on Agilent-C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelengths were set at 240 nm (paeoniflorin,psoralen,isopsoralen) and 290 nm (cinnamaldehyde).The column temperature was 35 ℃,and sample size was 10 μL.RESULTS:The linear ranges of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen were 0.004 02-0.100 6 mg/mL(r=0.999 8),0.024 50-0.612 7 mg/mL(r=0.999 8),0.005 24-0.131 0 mg/mL(r=0.999 9),0.005 11-0.127 8 mg/mL(r=0.999 9),respectively.LOQ were 37.17,1.47,21.76,25.57 ng,respectively;LOD were 11.15,0.44,6.53,7.67 ng,respectively.RSDs of precision,stability and reproducibility tests were all lower than 2.0％.The recoveries were 99.02％-100.83％ (RSD=0.68％,n=6),98.58％-100.99％ (RSD=0.83％,n=6),99.78％-101.69％ (RSD=0.89％,n=6),100.06％-102.46％ (RSD=0.92％,n=6),respectively.CONCLUSIONS:The method is simple,accurate and suitable for simultaneous determination of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen in Yaotong capsules.
ABSTRACT
OBJECTIVE:To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation.METHODS:Using hydrochloric acid solution (pH 3.0),phosphate buffer solution(pH 4.5),phosphate buffer solution (pH 6.8) and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min.UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 um.The similarity of dissolution curves were evaluated by calculating similarity factor(f2).RESULTS:The linear range of losartan potassium was 12.11-35.96 μg/mL (r≥0.999 7).RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries of 4 dissolution media were 98.66％-100.84％ (RSD=0.77％,n=9),98.91％-100.59％ (RSD=0.49％,n=9),98.33％-101.39％ (RSD=0.85％,n=9),99.46％-101.32％ (RSD=0.55％,n=9).In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70.CONCLUSIONS:The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.