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.

中文翻译：

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经验证的毛细管电泳法测定茚达特罗及其在药物制剂中的应用


茚达特罗是一种新型吸入式超长效β2激动剂。它最近在欧盟被批准用于治疗慢性阻塞性肺病。本文首次报道了一种使用胶囊内标物测定和验证茚达特罗 (IND) 的方法。在未涂层的熔融石英毛细管（50 cm 有效长度，75 μm 内径）和由 20 mmol L-1 四硼酸钠缓冲液、15% (v/v) 甲醇 (pH = 10.0) 组成的背景电解质上进行毛细管电泳分离。施加 20 kV 电位； 5 × 103 N m-2 (50 mbar) 注射时间为 10 秒；波长为 200 nm，温度为 25 °C。在 4.90 × 10-6 mol L-1 (2.50 μg mL-1) 和 3.94 × 10-5 mol L-1 (20.00 μg mL-1) 范围内评估线性，日间 R = 0.9993 。日间 LOD 和 LOQ 值分别为 2.18 × 10-8 mol L-1 (0.011 μg mL-1) 和 7.25 × 10-8 mol L-1 (0.037 μg mL-1)。日内精度值为 0.50-1.06%，日间精度值为 2.12%（RSD%）。采用标准添加法测定准确度，回收率百分比在98.79～99.09之间，RSD%区间为0.01～0.80。所开发的方法根据 ICH 指南进行了验证。通过经过验证的 CE 方法成功测定了 Arcapta® 胶囊剂型中的茚达特罗，相对误差为 0.28%。结果符合 USP 34-NF29 的要求。因此，经验证的方法可用于质量控制实验室测定茚达特罗胶囊中的含量。