A simple, precise, rapid and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for analysis of safinamide mesylate (SAF) in presence of its basic degradate, and co-administered drugs levodopa and ondansetron. The mobile phase consisted of acetonitrile and 20 mM potassium dihyrogen orthophosphate buffer having pH = 5 (40: 60 v/v). Quantification was achieved with ultraviolet detector at 226 nm. The linear range was 0.5–10 μg/mL with mean recovery ± SD of 99.72 ± 1.59. The peak purity of SAF in pharmaceutical preparation spiked with its degradate and co-administered drugs revealed symmetry factor (999.8) within the calculated threshold (>998.1). The suggested method was validated in compliance with the International Conference on Harmonization (ICH) guidelines and statistically compared with the manufacturer HPLC method with no significant difference in terms of accuracy and precision. The assay method was successfully used to estimate SAF in tablets with good percentage recoveries. The high sensitivity (lower than Cmax of the drug 0.65 μg/mL) of the proposed HPLC method enabled the determination of SAF in presence of its basic degradate and co-administered drug, ondansetron in human plasma with acceptable accuracy. The suggested HPLC method could be used in Quality Control (QC) lab for analysis of the studied drug in pharmaceutical preparation.

中文翻译：

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新的经过验证的RP-HPLC方法用于定量测定甲磺酸沙芬酰胺的基本降解物，左旋多巴和恩丹西酮：在人血浆中的应用。

开发了一种简单，精确，快速和准确的反相高效液相色谱（RP-HPLC）方法，并已验证该方法可在存在基本降解物的情况下对甲磺酸沙芬酰胺（SAF）进行分析，并与左旋多巴和恩丹西酮共同使用。流动相由乙腈和pH = 5（40：60 v / v）的20 mM正磷酸二氢钾缓冲液组成 ）。用紫外检测器在226 nm处进行定量。线性范围为0.5–10μg/ mL，平均回收率±SD为99.72±1.59。药物制剂中SAF的最高纯度加标了其降解和共同给药的药物，表明对称系数（999.8）在计算的阈值（> 998.1）之内。所建议的方法已按照国际协调会议（ICH）指南进行了验证，并与制造商的HPLC方法进行了统计比较，但在准确性和精密度方面无显着差异。该测定方法已成功用于估计回收率高的片剂中的SAF。所提出的HPLC方法的高灵敏度（低于药物的Cmax（0.65μg/ mL））使得能够在存在其基本降解药物和共同给药药物的情况下测定SAF，人体血浆中的恩丹西酮具有可接受的准确性。建议的HPLC方法可在质量控制（QC）实验室中用于分析药物制剂中所研究的药物。