Optimization of Formula and Preparation Process and Content Determination of Sorafenib Dry Suspension / 中国药师

ABSTRACT

Objective:To optimize the formula and preparation process of prepare sorafenib dry suspension and detect the content by HPLC. Methods:The influence of single factor including different fillers, suspending agents, adhesives and disintegrants on the sedimentation rate, redispersibility and drying shrinkage of sorafenib dry suspension was observed. Orthogonal design was used to opti-mize the formula and preparation process of the suspension, and HPLC was used to determine the content of sorafenib. The chromato-graphic column was Inertsil ODS-3 (250 mm × 4. 6 mm, 5μm), the mobile phase was 20 mmol·L-1 ammonium acetate buffer-aceto-nitrile(28 ∶72), the detection wavelength was 266 nm, the flow rate was 1. 0 ml·min-1, the column temperature was 40℃, and the sample size was 20 μl. Results:The optimal formula and preparation process were as followssucrose (48%) was used as the filler, xanthan gum (28%) and CMC-Na (12%) were the suspending agents, MCC (10%) was used as the disintegrant, and 6% PVP (in 50% ethanol) was the adhesive. The linear range of sorafenib was 1-100 μg·ml-1(r=0.999 8), and the recovery was 98.96%(RSD=0. 75%, n=9). Conclusion:The optimal formula and preparation process are repeatable. The HPLC method is simple and specific, which can be used to determine sorafenib.