A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation
Indacaterol is a new inhaled ultra-long acting β2-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 stan...
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doaj-f333c3fe844b4c1387e09eaa5565be912020-11-24T22:33:50ZengElsevierJournal of Food and Drug Analysis1021-94982018-04-01262842848A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparationTufan Güray0Muzaffer Tunçel1Ulku Dilek Uysal2Department of Chemistry, Faculty of Arts and Science, Eskisehir Osmangazi University, 26480, Eskisehir, Turkey; Corresponding author.Lefke European University, Faculty of Pharmacy, Department of Analytical Chemistry, Lefka, CyprusDepartment of Chemistry, Faculty of Science, Anadolu University, 26470, Eskişehir, TurkeyIndacaterol is a new inhaled ultra-long acting β2-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 μm 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 × 103 N m−2 (50 mbar) of injection time; and wavelength of 200 nm and 25 °C of temperature. The linearity was evaluated in the range of 4.90 × 10−6 mol L−1 (2.50 μg mL−1) and 3.94 × 10−5 mol L−1 (20.00 μg mL−1), with R = 0.9993 for inter-day. LOD and LOQ values were 2.18 × 10−8 mol L−1 (0.011 μg mL−1) and 7.25 × 10−8 mol L−1 (0.037 μg 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® 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. Keywords: Capillary electrophoresis, Determination, Indacaterol, Pharmaceuticalhttp://www.sciencedirect.com/science/article/pii/S1021949817301576 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Tufan Güray Muzaffer Tunçel Ulku Dilek Uysal |
spellingShingle |
Tufan Güray Muzaffer Tunçel Ulku Dilek Uysal A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation Journal of Food and Drug Analysis |
author_facet |
Tufan Güray Muzaffer Tunçel Ulku Dilek Uysal |
author_sort |
Tufan Güray |
title |
A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
title_short |
A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
title_full |
A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
title_fullStr |
A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
title_full_unstemmed |
A validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
title_sort |
validated capillary electrophoretic method for the determination of indacaterol and its application to a pharmaceutical preparation |
publisher |
Elsevier |
series |
Journal of Food and Drug Analysis |
issn |
1021-9498 |
publishDate |
2018-04-01 |
description |
Indacaterol is a new inhaled ultra-long acting β2-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 μm 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 × 103 N m−2 (50 mbar) of injection time; and wavelength of 200 nm and 25 °C of temperature. The linearity was evaluated in the range of 4.90 × 10−6 mol L−1 (2.50 μg mL−1) and 3.94 × 10−5 mol L−1 (20.00 μg mL−1), with R = 0.9993 for inter-day. LOD and LOQ values were 2.18 × 10−8 mol L−1 (0.011 μg mL−1) and 7.25 × 10−8 mol L−1 (0.037 μg 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® 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. Keywords: Capillary electrophoresis, Determination, Indacaterol, Pharmaceutical |
url |
http://www.sciencedirect.com/science/article/pii/S1021949817301576 |
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