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首页> 外文期刊>Journal of liquid chromatography and 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：一种稳定性指示HPTLC方法，用于分析散装药物和销售注射物中的Irinotecan

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摘要

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.
机译：根据ICH指南开发并验证了一种简单，敏感的薄层色谱法，用于分析INCOTECAN的高性能薄层色谱法，用于分析ININOTECAN。在硅胶60F254重精的铝板上实现色谱分离，如硅胶60F254为固定相。溶剂系统由丙酮 - 乙酸乙酯 - 乙酸8.5：1.5：0.1（v / v）组成，发现该系统在射频值为0.31±0.02的抗替替康的紧密斑点。在366nm的吸光度下进行密度计量分析。校准图的线性回归分析显示浓度范围为50-500ng /斑点的R2 = 0.9973 + - 0.0013的良好线性关系。验证该方法以获得精度，准确性，恢复和特异性。发现％回收率（94.63-101.40％）和精确（<= 4.30）令人满意。伊替康经酸和碱水解，氧化，热和紫外线辐射处理。所有降解产物的峰值从标准药物良好地分解，具有显着不同的保留因子（RF）值。开发方法从其降解产物中有效地分离出药物，因此可以用作稳定性指示方法以及Irinotecan的常规分析。

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