Simultaneous determination of eight bufadienolides in cinobufacini injection by HPLC coupled with triple quadrupole mass spectrometry.

A rapid and validated method was established for the simultaneous determination of eight active and toxic bufadienolides in cinobufacini injection using high performance liquid chromatography coupled with triple quadrupole mass spectrometry. These eight compounds were separated within 3 min on a C(18) analytical column with gradient elution. Eleven batches of cinobufacini injection were analyzed with good linear regression relationship (r, 0.9979-0.9999), precisions (RSD, 1.92-4.79%), repeatability (RSD, 3.12-4.96%), stability (RSD, 2.84-4.45%), and recovery (93.96-104.89%). By using the established method, the present study offered highly sensitive, specific, and speedy determination of eight bufadienolides, which promoted the quality control investigation of cinobufacini injection greatly.