Stability research of Compound Wurenchun Soft Capsule / 中成药

ABSTRACT

AIM:To research the stability of Compound Wurenchun Soft Capsule in 18 months. METHODS:TLC and HPLC methods were used.Schizandrol A was separated on a ODS-C_(18) column(Lichrospher ODS-C_(18),(4.6 mm?250 mm),) using methyl alcohol-water (65∶35) as the mobile phase,detected at 250 nm.The velocity of flow was 1.0 mL/min.Paeoniflorin was separated on a ODS-C column(Lichrospher ODS-C_(18),4.6 mm?250 mm),using acetonitrile-water-phophoric acid(15∶85) as the mobile phase,detected at 230 nm,the velocity of flow was 1.0 mL/min. RESULTS:There was a good linear relationship at the range of 0.04 mg/mL-0.64 mg/mL for schizandrol A(r=0.999 8).The average recovery of schizandrol A was 98.76%(n=6,RSD=1.18%).There was a good linear relationship at the range of 0.05 mg/mL-0.80 mg/mL for paeoniflorin(r=0.999 9).The average recovery of paeoniflorin was 97.93%(n=5,RSD=1.68%). CONCLUSION:In 18 months,the quality of Compound Wurenchun Soft Capsule is steady.