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Stability-indicating HPTLC determination of curcumin in bulk drug and pharmaceutical formulations

机译:稳定性指示HPTLC测定散装药物和药物制剂中的姜黄素

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摘要

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of curcumin both as bulk drug and in formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F- 254 as the stationary phase. The solvent system consisted of chloroform:methanol (9.25:0,75 v/v). This system was found to give compact cots for curcumin (Rf value of 0.48 +-0.02). Densitometric analysis of curcumin was carried out in the absorbance mode at 430 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r = 0.996 and 0.994 with respect to peak height and peak area, respectively, in the concentration range 50-300ng per spot. The mean value +- S.D, of slope and intercept were 1.08 +- 0.01, 51.93+-0.54 and 8 39+-0.21, 311.55 +-3.23 with respect to peak height and area, respectively. The method was validated for precision, very and robustness The limits of detection and quantitation were 8 and 25 ng per spot, respectively. Curcumin was subjected to acid nd alkali hydrolysis, oxidation and photodegradation. The drug undergoes degradation under acidic, basic, light and oxidation conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and photo oxidation. Statistical analysis proves that the method is tepeatable, selective and accurate for the estimation of said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.
机译:开发并验证了一种简单,选择性,精确和指示稳定性的高性能薄层色谱方法,用于分析姜黄素作为原料药和制剂的用途。该方法采用预涂硅胶60F-254的TLC铝板作为固定相。溶剂系统由氯仿:甲醇(9.25:0,75 v / v)组成。发现该系统提供了姜黄素的紧凑型婴儿床(Rf值为0.48 + -0.02)。姜黄素的光密度分析是在430 nm处的吸光度模式下进行的。校正图的线性回归分析数据显示,在每个斑点的浓度范围为50-300ng时,相对于峰高和峰面积,r = 0.996和0.994具有良好的线性关系。相对于峰高和峰面积,斜率和截距的平均值±SD为1.08±0.01、51.93±0.54和8±39±0.21、311.55±-3.23。经过验证,该方法具有较高的精密度,稳定性和鲁棒性。每个斑点的检测和定量限分别为8 ng和25 ng。姜黄素经过酸和碱水解,氧化和光降解。该药物在酸性,碱性,光和氧化条件下会降解。这表明该药物易受酸,碱水解,氧化和光氧化作用。统计分析证明,该方法对上述药物的估计具有可重复性,选择性和准确性。由于该方法可以有效地将药物与其降解产物分离,因此可以用作指示稳定性的方法。

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