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首页> 外文期刊>Open Chemistry >Validated thin-layer chromatographic method for alternative and simultaneous determination of two anti-gout agents in their fixed dose combinations
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Validated thin-layer chromatographic method for alternative and simultaneous determination of two anti-gout agents in their fixed dose combinations

机译：经过验证的薄层色谱法，可以同时确定固定剂量组合中的两种抗痛风药

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AbstractA rapid, simple and sensitive thin-layer chromatography (TLC) spectrodensitometric method was developed for the simultaneous determination of colchicine and probenecid in their binary mixtures. The two drugs were quantitatively separated using silica gel 60 F254 as stationary phase and toluene–ethyl acetate–methanol–ammonia (30:20:20:0.1, v/v/v/v) as mobile phase with UV detection at 248 nm for both drugs and at 354 nm for colchicine alone. Both drugs were efficiently separated with Rf values of 0.33±0.03 and 0.60±0.03 for probenecid and colchicine, respectively. The linearity was found to be 16–320 and 120–2400 (ng/band) with quantitation limits of 17.59 and 225.82 ng/band for colchicine and probenecid, respectively, at 248 nm. At 354 nm, the linearity range of colchicine was found 16–240 ng/band with a quantitation limit of 54.03 ng/band. The experimental determination ranges were greatly extended with lower quantitation limits (15.60 and 116.13 ng/band for colchicine and probenecid, respectively at 248 nm, and 13.20 for colchicine at 354 nm) and correlation coefficients were improved when polynomial regression analysis was used. The quadratic model was found to be the best fit for all responses. The method has been validated according to the International Conference on Harmonization (ICH) guidelines providing good correlation coefficients (0.9997-0.9999) for both drugs, and it has been successfully applied in the determination of both drugs in their commercial dosage form without interference from excipients.
机译：摘要建立了一种快速，简单和灵敏的薄层色谱（TLC）光密度法，用于同时测定秋水仙碱和丙磺舒的二元混合物。两种药物分别用硅胶60 F254作为固定相和甲苯-乙酸​​乙酯-甲醇-氨（30：20：20：0.1，v / v / v / v）作为流动相进行定量分离，并在248 nm处进行UV检测两种药物，单独的秋水仙碱在354 nm处。两种药物均有效分离，丙磺舒和秋水仙碱的Rf值分别为0.33±0.03和0.60±0.03。发现线性度为16–320和120–2400（ng / band），秋水仙碱和丙磺舒在248 nm处的定量限分别为17.59和225.82 ng / band。在354 nm处，秋水仙碱的线性范围为16–240 ng / band，定量限为54.03 ng / band。通过较低的定量限（秋水仙碱和丙磺舒在248 nm处分别为15.60和116.13 ng / band，在354 nm的秋水仙碱为13.20处）大大提高了实验测定范围，当使用多项式回归分析时，相关系数得到了改善。发现二次模型最适合所有响应。该方法已根据国际协调会议（ICH）指南进行了验证，可为两种药物提供良好的相关系数（0.9997-0.9999），并且已成功用于两种药物的商业剂型测定中，而不受辅料的干扰。

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