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Development and Validation of an Extractive Spectrophotometric Method for Miconazole Nitrate Assay in Pharmaceutical Formulations

机译:药物制剂中咪康唑硝酸盐测定萃取分光光度法的开发与验证

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A simple extractive spectrophotometric technique has been developed and validated for the determination of miconazole nitrate in pure and pharmaceutical formulations. The method is based on the formation of a chloroform-soluble ion-pair complex between the drug and bromocresol green (BCG) dye in an acidic medium. The complex showed absorption maxima at 422 nm, and the system obeys Beer’s law in the concentration range of 1–30 µg/mL with molar absorptivity of 2.285 × 104 L/mol/cm. The composition of the complex was studied by Job’s method of continuous variation, and the results revealed that the mole ratio of drug  BCG is 1  1. Full factorial design was used to optimize the effect of variable factors, and the method was validated based on the ICH guidelines. The method was applied for the determination of miconazole nitrate in real samples.
机译:已经开发了一种简单的萃取分光光度法,并验证了纯和药物制剂中咪康唑硝酸盐的测定。该方法基于在酸性介质中药物和溴甲酚绿(BCG)染料之间的氯仿可溶性离子对复合物的形成。该复合物在422nm处显示出吸收最大值,并且系统在浓度范围内的摩尔吸收率为2.285×104l / mol / cm的浓度范围内的系统。通过作业的连续变化方法研究了复合物的组成,结果表明,药物BCG的摩尔比为1 1.完整的因子设计用于优化可变因素的效果,并且基于以下方法验证该方法Ich准则。该方法用于测定真实样品中硝酸咪康唑。

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