曲线下面积分光光度法测定药物制剂中洛伐他汀的含量

S. Dhobale, V. Narad, D. Gaikwad
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引用次数: 2

摘要

建立一种准确、简便、经济的紫外分光光度法测定洛伐他汀的方法是本研究的目的。这项工作是基于曲线下面积法,即“感兴趣成分的浓度与混合光谱上两点下的面积成正比”。选取238 ~ 258 nm的紫外光谱,按照ICH指南Q2 (R1)进行验证。该方法在5 ~ 25μg /ml浓度范围内符合比尔兰伯特定律。相关系数为0.9988。日内、日内精密度相对标准偏差百分比满意,方法精度较高。回收率为99.8,证明了方法的准确性。因此,该方法可用于洛伐他汀原料药和剂型的常规估计。
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Estimation of Lovastatin in Pharmaceutical Formulation by Area under Curve Spectrophotometric Method
Development of an accurate, simple and cost effective UV spectrophotometric method for estimation of Lovastatin was the aim of present study. This work was based upon an area under curve method i.e. “concentration of the component of interest is directly proportional to the area under two points on the mixture spectra”. The UV spectrum between 238-258 nm was selected and the validation was carried out as per ICH guideline, Q2 (R1). This method obeyed Beer’s Lamberts Law over the concentration range of 5-25μg /ml. The value of correlation coefficient was 0.9988. The method was precise due to the satisfactory value of percent relative standard deviation for the intraday and inter-day precision. Result of the recovery studies (99.8) showed accuracy of method. Hence, developed method can be used for routine estimation of Lovastatin in bulk and dosage form.
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