Development and statistically validated UV spectrophotometric determination of testosterone in gel formulation

Kartik Bhagat, A. V. Ganorkar, A. Hemke, K. Gupta
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引用次数: 1

Abstract

Objective : A simple, precise and accurate UV-spectrophotometric method is developed and statistically validated for estimation of Testosterone in gel formulation. The proposed method includes using regression equation, area under curve (AUC), first order derivative and second order derivative spectroscopic method. Methods : based on measurement of absorbance at a selected wavelength using UV-visible spectrophotometer with 1cm matched quartz cell and acetonitrile as a solvent. All developed methods obeyed Beer’s-lambert’s law in the concentration range of 5-25μg/mL, with correlation coefficient value less than 1. Results : The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of marketed gel formulation. The recovery study was carried out at three different levels, the validation study data was found to be statistically significant as all the statistical parameters are within the acceptance range (% RSD <2.0 and S.D. <±2.0). Conclusions : The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The results obtained were statistically compared using paired t-test and one way ANOVA analysis. The proposed method can be adopted for routine quality control for estimation of drug in formulation.
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开发和统计验证紫外分光光度法测定凝胶制剂中的睾酮
目的:建立一种简便、精确、准确的紫外分光光度法测定凝胶制剂中睾酮含量的方法。该方法包括回归方程法、曲线下面积法、一阶导数法和二阶导数光谱法。方法:采用紫外可见分光光度计,以乙腈为溶剂,用1cm匹配的石英池测定在选定波长处的吸光度。所建立的方法在5 ~ 25μg/mL浓度范围内均符合比尔-朗伯定律,相关系数值均小于1。结果:所估算的药量百分比接近100%,与上市凝胶制剂的标签声明吻合较好。回收率研究分三个不同水平进行,所有统计参数均在可接受范围内(% RSD <2.0, sd <±2.0),验证研究数据具有统计学意义。结论:对所建立方法的准确度、精密度、稳健性、线性度、范围等参数的估计和验证结果进行了研究,均在限定范围内。所得结果采用配对t检验和单因素方差分析进行统计学比较。该方法可用于制剂中药物的常规质量控制。
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