Assay for the determination of low dosage form of formoterol dry syrup by capillary electrophoresis with head-column field-amplified sample stacking.
The development of a capillary zone electrophoresis method with head-column field-amplified sample stacking injection for the determination of formoterol (FMTR) in a low dosage dry syrup form was described. To obtain the highest sensitivity, the sample solution was prepared by high content of organic solvent with the presence of a small amount of H+ (60-100 microM) and the capillary inlet end was dipped in water before electroinjection. This method was fully validated in terms of repeatability (RSDs for migration time, peak area of FMTR and peak area ratio between FMTR and I.S. at 1 microg/ml of FMTR was 0.76, 1.10 and 0.55% respectively), reproducibility (RSDs from different capillaries, analytes, days and instruments were 1.52%, 1.04%, 1.16% and 1.93% respectively), linearity (y = 0.827x - 0.085, r = 0.9993 (n = 6) over the range of 0.25-2.0 microg/ml), limits of quantitation, ruggedness and robustness. The method was applied to the determination of the drug in commercial dry syrup preparation (recovery was 100.9%, RSD = 1.5%, n = 5) and proved to be fast and reliable for the quantitation analysis of FMTR in the pharmaceutical form.
Song
J Z
JZ
National Institute for the Control of Pharmaceutical and Biological Products of China, Temple of Heaven, Beijing, People's Republic of China.
Chen
J
J
Tian
S J
SJ
Sun
Z P
ZP
D001993:Bronchodilator Agents / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D019075:Electrophoresis, Capillary / Q000379:methods*; D004983:Ethanolamines / Q000032:analysis*; D000068759:Formoterol Fumarate; D011786:Quality Control; D015203:Reproducibility of Results
D001993:Bronchodilator Agents; D004983:Ethanolamines; D000068759:Formoterol Fumarate