Abstract:
OBJECTIVE To establish two efficient method to determine the polymers in cefaclor dispersible tablets and compare the results of two methods.
METHODS Method 1:TSK-GEL G2000
SWXL column (7.8 mm×300 mm, 5 μm) was used. Mobile phase was 0.01 mol·L
-1 phosphate buffer solution0.01 mol·mL
-1 disodium hydrogen phosphate-0.01 mol·mL
-1 sodium dihydrogen phosphate (50︰50), pH=7.0-acetonitrile (95︰5), and the flow rate was 0.5 mL·min
-1, the temperature of column was kept at 35℃, the detection wavelength was at 254 nm, the injection volume was 20 μL. Method 2:Sephadex G-10 column (10.0 mm×300 mm, 40-120 μm) was used. Mobile phase A was 0.05 mol·L
-1 phosphate solution0.05 mol·mL
-1 disodium hydrogen phosphate and 0.05 mol·mL
-1 sodium dihydrogen phosphate (50︰50), pH=7.0, mobile phase B was water and the flow rate was 1 mL·min
-1, the temperature of column was kept at 35,℃ the detection wavelength was at 254 nm, the injection volume was 100 μL.
RESULTS Method 1:the resolution between main peak of cefaclor and polymer impurity peak was >1.5; the linear range of cefaclor was 0.25-20 μg·mL
-1 (
r=0.999 9). The LOD and LOQ of were found to be 0.07 μg and 0.21 μg; the repeatability RSD (
n=6) was 1.8%. Method 2:the linear of cefotaxime was 2.5-20 μg·mL
-1 (
r=0.999); the LOD and LOQ of were found to be 0.13 μg and 0.40 μg; the repeatability RSD (
n=6) was 1.8%.
CONCLUSION The two method can be used in determination of the polymer in cefaclor. The two improved methods show higher sensitivity, better separation ability, simple application and good reproducibility for cefaclor dispersible tablets. They can be used as the quality control of cefaclor dispersible tablets foundation.