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首页> 外文期刊>RSC Advances >Stress stability study of simeprevir, a hepatitis C virus inhibitor, using feasible TLC-spectro-densitometry: application to pharmaceutical dosage form and human plasma
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Stress stability study of simeprevir, a hepatitis C virus inhibitor, using feasible TLC-spectro-densitometry: application to pharmaceutical dosage form and human plasma

机译：使用可行性TLC光谱 - 光谱 - 密度测定法的Simeprevir，丙型肝炎病毒抑制剂的应力稳定性研究：药物剂型和人血浆的应用

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摘要

Simeprevir is one of the newest direct action anti-hepatitis C drugs. In the present work, a simple, highly selective and stability-indicating, high-performance thin-layer chromatography (HPTLC) method is proposed and validated for the assay of simeprevir both in pharmaceutical dosage form and spiked human plasma. The method used silica gel 60 F _(254) coated HPTLC aluminum plates as the stationary phase. The mobile phase system was ethyl acetate-hexane-methanol (5?:?4?:?1, v/v/v). The wavelength for both detection and quantitation was set at 288 nm. This system was found to give a compact spot of simeprevir; the retardation factor ( R _(F) ) value was 0.67 ± 0.02. The guidelines of the International Conference on Harmonization were followed to validate the proposed analytical method, and the results were acceptable. The calibration curve was linear over the range of 80–1000 ng per spot. The limit of detection was 19.0 ng per spot, and the limit of quantitation was 57.0 ng per spot. The drug was subjected to various stress conditions including hydrolytic, oxidative and UV-induced resulting in varying degrees of degradation. The results showed that the proposed method could efficiently separate the degradation products from the intact drug and allow its satisfactory quantitation. The proposed method was employed successfully for the accurate and reproducible analysis of the pharmaceutical preparation and human plasma containing the drug. The proposed method's precision and accuracy were statistically similar to those of a reported method.
机译：Simeprevir是最新的直接动作抗丙型肝炎药物之一。在本作工作中，提出了一种简单，高度选择性和稳定性的，高性能薄层色谱（HPTLC）方法，并验证了Simeprevir的测定，两者都在药物剂型和尖刺的人血浆中。该方法使用硅胶60f_（254）涂覆的HPTLC铝板作为固定相。流动相体系是乙酸乙酯 - 己烷 - 甲醇（5？：4？：α1，v / v）。检测和定量的波长设定为288nm。发现该系统提供了Simeprevir的紧凑型;延迟因子（R _（F））值为0.67±0.02。遵循国际协调会议的指导方针验证拟议的分析方法，结果是可接受的。校准曲线是线性的，范围为80-1000ng。检测限为19.0 ng /点，定量限为57.0 ng。对药物进行各种应激条件，包括水解，氧化和UV诱导，导致不同程度的降解。结果表明，该方法可以有效地将降解产物与完整药物分离并允许其令人满意的定量。所提出的方法成功地用于准确可再现的药物制剂和含有药物的人血浆的分析。所提出的方法的精确度和准确性与报告方法的精度相似。

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