A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation

Abstract

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.