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Development and Validation of HPTLC Method for the Estimation of Clotrimazole in Bulk drug and Tablet Formulation

机译:高效液相色谱法测定散装药物克霉唑和片剂的估算方法的建立和验证

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摘要

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the determination of clotrimazole in bulk drug and tablet dosage form. The stationary phase used was precoated silica gel 60F254. The mobile phase used was a mixture of cyclohexane:toluene:methanol:triethyleamine (8:2:0.5:0.2 v/v/v/v). The detection of spot was carried out at 262 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 200 to 1000 ng/spot for clotrimazole. The limit of detection and the limit of quantification for clotrimazole were found to be 50 ng/spot and 200 ng/spot, respectively. The proposed method can be successfully used to determine the drug content of bulk drug and marketed formulation of tablet.
机译:已经开发了一种简单,精确,准确和快速的高性能薄层色谱方法,并已用于测定散装药物和片剂剂型中的克霉唑。所使用的固定相是预涂硅胶60F254。所使用的流动相是环己烷:甲苯:甲醇:三乙胺的混合物(8:2:0.5:0.2 v / v / v / v)。点的检测在262nm进行。该方法已通过线性,准确性,精密度和特异性方面的验证。发现克霉唑的校准曲线在200至1000 ng / s之间呈线性。发现克霉唑的检出限和定量限分别为50 ng / spot和200 ng / spot。所提出的方法可以成功地用于确定散装药物的含量和市售的片剂。

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