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首页> 外文期刊>Journal of Liquid Chromatography & Related Technologies >A STABILITY INDICATING HPTLC METHOD FOR THE ANALYSIS OF IRINOTECAN IN BULK DRUG AND MARKETED INJECTABLES
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A STABILITY INDICATING HPTLC METHOD FOR THE ANALYSIS OF IRINOTECAN IN BULK DRUG AND MARKETED INJECTABLES

机译：用于散装药品和市场营销的注射物中伊立替康的稳定性指示HPTLC方法

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A simple, sensitive, precise, and accurate stability-indicating high performance thin-layer chromatographic method for analysis of irinotecan both as bulk drug and in marketed injectables has been developed and validated as per ICH guidelines. Chromatographic separation was achieved on LiChrospher aluminum plates precoated with silica gel 60F254 as stationary phase. The solvent system consisted of acetone-ethyl acetate-acetic acid 8.5:1.5:0.1 (v/v/v) and this system was found to give compact spots for irinotecan at RF value of 0.31 ± 0.02. Densitometric analysis was performed in the absorbance at 366 nm. The linear regression analysis for the calibration plots showed good linear relationship with r2 = 0.9973 ± 0.0013 in the concentration range of 50-500 ng/spot. The method was validated for precision, accuracy, recovery, and specificity. The % recovery (94.63-101.40%) and precision (≤4.30) were found to be satisfactory. Irinotecan was subjected to acid and alkali hydrolysis, oxidation, thermal, and ultraviolet radiation treatments. All the peaks of degradation products were well resolved from the standard drug with significantly different retention factor (RF) values. Developed method effectively separated out the drug from its degradation products and hence can be used as stability-indicating method as well as in routine analysis of irinotecan.View full textDownload full textKeywordsdegradation, high-performance thin-layer chromatography, irinotecan, stabilityRelated var addthis_config = { ui_cobrand: "Taylor & Francis Online", services_compact: "citeulike,netvibes,twitter,technorati,delicious,linkedin,facebook,stumbleupon,digg,google,more", pubid: "ra-4dff56cd6bb1830b" }; Add to shortlist Link Permalink http://dx.doi.org/10.1080/10826076.2011.572214
机译：根据ICH指南，已开发并验证了一种简单，灵敏，精确和准确的稳定性指示高性能薄层色谱方法，用于分析作为主要药物和市售注射剂的伊立替康。在预先涂有硅胶60F254作为固定相的LiChrospher铝板上完成色谱分离。溶剂系统组成的丙酮-乙酸乙酯-乙酸8.5：1.5：0.1（v / v / v），并且发现该系统可以为伊立替康提供紧凑的斑点，RF值为0.31±0.02。在366 nm的吸光度中进行光密度分析。校准图的线性回归分析表明在50-500 ng /点的浓度范围内与r2 = 0.9973±0.0013具有良好的线性关系。验证了该方法的准确性，准确性，回收率和特异性。 ％回收率（94.63-101.40％）和精度（≥4.30）被发现是令人满意的。伊立替康经过酸和碱水解，氧化，热和紫外线辐射处理。降解产物的所有峰均可以通过标准药物得到很好的分离，保留因子（RF）值明显不同。所开发的方法可以有效地从降解产物中分离出药物，因此可以用作稳定性指示方法以及伊立替康的常规分析方法。全文下载关键词降解，高效薄层色谱法，伊立替康，稳定性相关变量var addthis_config = {ui_cobrand：“ Taylor＆Francis Online”，servicescompact：“ citeulike，netvibes，twitter，technorati，delicious，linkedin，facebook，stumbleupon，digg，google，更多”，发布：“ ra-4dff56cd6bb1830b”}；添加到候选列表链接永久链接http://dx.doi.org/10.1080/10826076.2011.572214

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