Abstract:
The (
R)-lansoprazole powder for injection was dissolved in methanol to prepare a 5.00 mg·L
-1 sample solution, and chromatographic analysis was carried out under the following conditions:Chiralpak ID chiral column (4.6 mm×250 mm, 5 μm) was used as stationary phase, the column temperature was 35℃, the mobile phase was a mixture of
n-hexane, isopropanol and glacial acetic acid (70+30+0.2), the flow rate was 0.6 mL·min
-1, and the diode array detector was used for detection at the wavelength of 285 nm. The results showed that, linear relationship was found between peak area and mass concentration of (
S)-lansoprazole in the range of 0.48-4.81 mg·L
-1, the detection limit (3S/N) was 2.4×10
-3mg·L
-1, and the lower limit of determination (10S/N) was 4.8×10
-3mg·L
-1. Values of recovery obtained by standard addition method were in the range of 97.5%-103%, and RSDs (
n=6) were less than 1.6%.