Method development and validation of clobazam in bulk and pharmaceutical dosage forms by using high performance thin layer chromatographic method

C. R., Senthil Kumar Gp, P. P, Vidya Dn, Bhadresh Dr, M. S
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Abstract

In the present research a simple, accurate, precise and cost-effective High-performance thin layer chromatographic method for the estimation of clobazam, in bulk and pharmaceutical dosage form was illustrated. The RF value of the drug was found to be 0.74 in the mobile phase, acetone: toluene: formic acid (1: 1: 0.05 v/v/v). A linear response was observed in the range of 100-700 ng with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of clobazam to analyze the quality of formulation without interference of the excipients. 
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高效薄层色谱法测定氯巴唑原料药和制剂的方法建立和验证
本文介绍了一种简便、准确、精密度高、性价比高的高效薄层色谱法测定氯巴唑原料药和制剂中氯巴唑的含量。在丙酮:甲苯:甲酸(1:1:0.05 v/v/v)的流动相中,发现该药物的RF值为0.74。在100 ~ 700 ng范围内呈线性响应,回归系数为0.999。验证参数按照国际协调会议(ICH)的指导方针进行。该方法可用于氯巴嗪制剂的质量分析,不受辅料的干扰。
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