Akademik Veri Yönetim Sistemi
JOURNAL OF FOOD AND DRUG ANALYSIS, cilt.26, sa.2, ss.842-848, 2018 (SCI-Expanded)
Indacaterol is a new inhaled ultra-long acting beta(2)-agonist. It has been recently approved in the European Union for the treatment of chronic obstructive pulmonary disease. This paper reports, for the first time, a method for the determination and validation of Indacaterol (IND) using an internal standard in capsules. Capillary electrophoretic separation was performed on an uncoated fused-silica capillary (50 cm effective length, 75 mu m i.d.) and background electrolyte composed of 20 mmol L-1 of sodium tetraborate buffer, 15% (v/v) methanol (pH = 10.0) with the application of 20 kV of potential; 10 s at 5 x 10(3) N M-2 (50 mbar) of injection time; and wavelength of 200 nm and 25 degrees C of temperature. The linearity was evaluated in the range of 4.90 x 10(-6) mol L-1 (2.50 mu g mL(-1)) and 3.94 x 10(-5) mol L-1 (20.00 mu g mL(-1)), with R = 0.9993 for inter-day. LOD and LOQ values were 2.18 x 10(-8) mol L-1 (0.011 mu g mL(-1)) and 7.25 x 10(-8) mol L-1 (0.037 mu g mL(-1)) for inter-day, respectively. The precision values were 0.50-1.06% for intra-day and 2.12% for inter-day as RSD%. The accuracy was tested by the standard addition method with the recovery values being between 98.79 and 99.09 as percentages with RSD% interval of 0.01-0.80. The developed method was validated according to ICH guidelines. Indacaterol was successfully determined in Arcapta((R)) capsule dosage form by the validated CE method with a relative error of 0.28%. The result was within the requirements of the USP 34-NF29. Therefore, the validated method may be used for the determination of Indacaterol in its capsules in quality control laboratories. Copyright (C) 2017, Food and Drug Administration, Taiwan. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license.