首页> 外文期刊>Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry >Development and validation of UV spectrophotometric method for the estimation of asenapine maleate in bulk and pharmaceutical formulation
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Development and validation of UV spectrophotometric method for the estimation of asenapine maleate in bulk and pharmaceutical formulation

机译:紫外分光光度法估计马来酸阿塞那平和药物制剂的开发与验证

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A simple, accurate, precise and sensitive UV spectrophotometric method was developed for the determination of Asenapine maleate in bulk and pharmaceutical dosage form. The solvent used is methanol and the wavelength corresponding to maximum absorbance of the drug was found at 270nm. Beers law was observed in the concentration range of 10- 60μg/ml with correlation coefficent 0.9997. The linear regression equation obtained by least square regression method were y=0.0132X-0.0016, where y is the absorbance and x is the concentration of the pure drug solution. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of relative standard deviation and % recovery were found to be satisfactory, indicating that the proposed method is precise and accurate and hence can be used for the routine analysis of Asenapine maleate in bulk and pharmaceutical formulation.
机译:开发了一种简单,准确,精确和灵敏的紫外分光光度法,用于测定散装和药物剂型的马来酸阿塞那平。所使用的溶剂是甲醇,并且对应于药物最大吸收的波长在270nm处发现。在10-60μg/ ml的浓度范围内观察到比尔斯定律,相关系数为0.9997。通过最小二乘回归法获得的线性回归方程为y = 0.0132X-0.0016,其中y为吸光度,x为纯药物溶液的浓度。根据ICH指南,该方法已针对多个参数进行了验证,例如准确性,准确性。发现相对标准偏差和回收率%的值令人满意,表明所提出的方法准确,准确,因此可用于散装和药物制剂中马来酸阿塞那平的常规分析。

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