Utilization of the FTIR spectroscopic method for the quantitative determination of the narrow therapeutic index levothyroxine sodium in pharmaceutical tablets

Pharmacia Pub Date : 2024-07-01 DOI:10.3897/pharmacia.71.e125879

Malak AlBathish, A. Gazy, Marwa Al Jamal, A. Bejjani

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Abstract

Levothyroxine sodium is a narrow therapeutic index drug used for the treatment of hypothyroidism. The medication is marketed in tablet form with very low doses ranging from 25 to 150 µg, which requires the development of a sensitive quantitative analytical method to ensure a safe and effective pharmacological response. In the present work, a Fourier transform infrared method has been developed and validated for levothyroxine sodium determination in various pharmaceutical formulations. The proposed method involves selectively extracting levothyroxine sodium from the studied tablets using chloroform as solvent, then depositing it on a KBr pellet, followed by infrared measurements and spectra analysis. The peak band area corresponding to the C=C centered at 1409 cm-1 has been chosen for the quantification. The method has been validated according to ICH guidelines and was found to be simple, precise, accurate, and specific. The linearity, detection, and quantitation limits are 25–800, 8.121, and 24.545 µg/pellet, respectively. These values confer the method’s sensitivity and applicability for the determination of different pharmaceutical tablets with various dosages. A statistical comparison with a reference HPLC method showed no significant difference. Accordingly, the developed method can be employed for quality control testing of levothyroxine sodium due to its simplicity and the absence of sophisticated instrumentation and procedures. Graphical abstract:

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利用傅立叶变换红外光谱法定量测定药片中治疗指数较窄的左甲状腺素钠的含量

左甲状腺素钠是一种治疗甲状腺功能减退症的窄治疗指数药物。这种药物以片剂形式上市，剂量非常小，从 25 微克到 150 微克不等，因此需要开发一种灵敏的定量分析方法，以确保安全有效的药理反应。本研究开发并验证了一种傅立叶变换红外方法，用于测定各种药物制剂中的左旋甲状腺素钠。所建议的方法是以氯仿为溶剂，选择性地从所研究的片剂中提取左旋甲状腺素钠，然后将其沉积在 KBr 颗粒上，接着进行红外测量和光谱分析。选择以 1409 cm-1 为中心、与 C=C 相对应的峰带区域进行定量。根据 ICH 指南对该方法进行了验证，结果表明该方法简单、精确、准确、特异。线性、检测和定量限分别为 25-800、8.121 和 24.545 微克/颗粒。这些数值证明了该方法的灵敏度和适用性，可用于测定不同剂量的不同药物片剂。与参考的高效液相色谱法进行统计比较，结果显示两者无明显差异。因此，该方法操作简单，无需复杂的仪器和程序，可用于左甲状腺素钠的质量控制检测。图表摘要：

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Pharmacia

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