曲线下面积分光光度法测定制剂中厄贝沙坦的含量

S. Alexandar, A. Santhanam, C. Sandhu, C. Sanjaykanth, S. Sandhya, G. S. Kumar, B. Jaykar
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引用次数: 1

摘要

建立了分光光度法测定厄贝沙坦含量的新方法。目前尚无曲线下面积分光光度法测定厄贝沙坦剂型的报道。本文研究了用曲线下面积法测定药物剂型中厄贝沙坦含量的方法。AUC曲线法的原理是“混合光谱两点下的面积与感兴趣成分的浓度成正比”。厄贝沙坦的测定范围为203 ~ 211 nm。厄贝沙坦在5 ~ 25 μg/ml的浓度范围内符合贝尔-朗伯定律。在准确度研究中,厄贝沙坦在原料药样品中的回收率为96.45 ~ 93.84%,表明该方法是准确的。根据ICH指南对该方法的准确性、精密度和特异性进行验证。该方法可成功地应用于替加环素制剂剂型的测定工作。
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Area Under the Curve Spectrophotometric Method for Determination of Irbesatran in Pharmaceutical Formulation
This study presents new spectrophotometric method for the determination of Irbesartan. So far, no Area under Curve Spectrophotometric method has been reported for the estimation of Irbesartan from pharmaceutical dosage form. This paper deals with validation and development of a method by Area Under Curve for the assay of Irbesartan from pharmaceutical dosage forms. The principle for AUC curve method is “the area under two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The area selected between 203 to 211 nm for determination of Irbesartan. The drug follows Beer-Lambert’s law over the concentration range of 5-25 μg/ml for Irbesartan. In accuracy study the % recovery of Irbesartan in bulk drug samples was ranged 96.45-93.84%, which indicates that the method was accurate. Validation of the proposed method was carried out for its accuracy, precision, and specificity according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of Tigecycline in its pharmaceutical dosage form.
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