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Zero and first order derivative UV spectrophotometric methods for determination of efavirenz in pharmaceutical formulation

机译:零阶和一阶导数紫外分光光度法测定药物制剂中的依非韦伦

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Two Simple, fast and reliable derivative spectrophotometric methods were developed for determination of efavirenz in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 239 nm and the first order derivative values measured at 248 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of efavirenz using 5-40 μg.mL-1 (r² = 0.9997 and r² = 0.9998) for zero order and first order derivative spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. These methods were successfully applied to pharmaceutical formulations because no interferences from tablet excipients were found. The proposed methods were found to be simple, sensitive, accurate, precise, rapid and economical for the routine quality control application of efavirenz in pharmaceutical formulations.
机译:开发了两种简单,快速和可靠的衍生分光光度法,用于测定散装和药物剂型中的依非韦伦。标准溶液和样品在甲醇中制备。使用在239 nm处测得的零阶导数和在248 nm处测得的一阶导数进行药物的定量测定。在依非韦伦的浓度范围内,按5阶和一阶导数分光光度法,在依非韦伦的浓度范围内建立的校准图呈线性关系,使用5-40μg.mL-1(r²= 0.9997和r²= 0.9998)。所有提出的方法均已按照ICH指南进行了广泛验证。就平均值和标准偏差而言,所提出方法的性能之间没有显着差异。这些方法已成功应用于药物制剂,因为未发现片剂赋形剂的干扰。对于依法韦仑在药物制剂中的常规质量控制应用,发现所提出的方法简单,灵敏,准确,精确,快速且经济。

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