OBJECTIVETo establish the method for determining polysorbate 80 in Reduning injection by HPLC-ELSD, and to control the mass of polysorbate 80 in Reduning injection.

METHODIt was performed by HGPC-ELSD with TOSHTSK-GEL G4000PWxl (7.8 mm x 300 mm, 10 μm). Water was used as mobile phase, the flow rate was 0.7 mL x min(-1), and the temperature was set at 30°C. The evaporated light scattering detector was adopted. The drift tube temperature was 55°C, and nitrogen was used as carrier gas, with the flow rate of 2.0 L x min(-1) and gain of 1.0.

RESULTThe calibration curve showed good linearity of polysorbate 80 in the test range from 1.01 to 15.20 g x L(-1) (r2 = 0.999 3). The recovery rate was 98.10% with RSD of 2.0%.

CONCLUSIONThe method is simple, rapid, accurate and reliable and suitable for the determination of polysorbate 80 in Reduning injection.