Development, Validation, and Quantification of Organic Impurities with Mass Balance in the Levodopa and Benserazide Hydrochloride Pharmaceutical Dosage Form

IF 1 4区 化学 Q4 CHEMISTRY, ANALYTICAL Journal of Analytical Chemistry Pub Date : 2024-11-01 DOI:10.1134/S1061934824700990
B. S. Mehetre, K. T. Waghmode, S. S. Gurav
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Abstract

A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed to determine organic impurities in a combination drug containing levodopa and benserazide, frequently used in the treatment of Parkinson’s disease. The determination of impurities holds significant importance in combination products, as their higher occurrence impacts both the quality and bio-efficacy of the drug products. Thus, the current RP-HPLC method aims to identify organic impurities, providing simplicity, effectiveness, and reproducibility. A Zorbax SB C18 column (4.6 × 250 mm, 5 μm) was utilized, with a flow rate of 1.0 mL/min and a detection wavelength of 220 nm. The analysis was conducted in isocratic mode with an ambient (25°C) column temperature and a 5°C autosampler temperature. Further, enhanced peak resolution was achieved by employing an iron pair agent. All impurities were effectively separated, and peak purity analysis confirmed the absence of interference for levodopa and benserazide. Accuracy, precision, and linearity were well within acceptable criteria, with the method signifying a correlation coefficient above 0.995 for known impurities of levodopa and benserazide. The method validation, following ICH quality guidelines, exhibited the specificity of the developed method, while the robustness study confirmed its reliability under diverse conditions. Thus, mutual results indicate the pragmatism and applicability of the developed method, reinforcing safe and efficacious therapeutics for patients.

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左旋多巴和盐酸苄丝肼药物剂型中有机杂质质量平衡的开发、验证和定量
本研究开发了一种稳定性指示反相高效液相色谱(RP-HPLC)方法,用于测定一种常用于治疗帕金森病的含有左旋多巴和苄丝肼的复方药物中的有机杂质。杂质的测定在复方产品中具有重要意义,因为杂质的较高出现率会影响药物产品的质量和生物功效。因此,目前的 RP-HPLC 方法旨在鉴定有机杂质,具有简便、有效和可重复性的特点。采用 Zorbax SB C18 色谱柱(4.6 × 250 mm,5 μm),流速为 1.0 mL/min,检测波长为 220 nm。分析在等度模式下进行,色谱柱温度为 25°C,自动进样器温度为 5°C。此外,通过使用铁对剂提高了峰分辨率。所有杂质均得到有效分离,峰纯度分析证实左旋多巴和苄丝肼不存在干扰。该方法的准确度、精密度和线性度均符合可接受的标准,对已知杂质左旋多巴和苄丝肼的相关系数高于 0.995。按照 ICH 质量指南进行的方法验证显示了所开发方法的特异性,而稳健性研究则证实了该方法在各种条件下的可靠性。因此,共同的结果表明了所开发方法的实用性和适用性,从而加强了对患者安全有效的治疗。
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来源期刊
Journal of Analytical Chemistry
Journal of Analytical Chemistry 化学-分析化学
CiteScore
2.10
自引率
9.10%
发文量
146
审稿时长
13 months
期刊介绍: The Journal of Analytical Chemistry is an international peer reviewed journal that covers theoretical and applied aspects of analytical chemistry; it informs the reader about new achievements in analytical methods, instruments and reagents. Ample space is devoted to problems arising in the analysis of vital media such as water and air. Consideration is given to the detection and determination of metal ions, anions, and various organic substances. The journal welcomes manuscripts from all countries in the English or Russian language.
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