Analytical Method Development and Validation for Estimation of Metformin in Bulk and Pharmaceutical Dosage Form by UV Spectrometric Method

Mayur Patni, S. Rawat
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引用次数: 1

Abstract

A rapid, simple, selective and precise UVVisible Spectrophotometric method has been developed for the determination of metformin hydrochloride in bulk forms and tablet dosage formulations. The spectrophotometric detection was as per carried out at an absorption maximum of 232 nm using phosphate buffer of pH 6.8 as solvent. The method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness. The detector response for was linear over the selected concentration range 2 to 12μg/ml with a correlation coefficient of 0.994. The accuracy was carried out as per recovery study and found between 99.1 % to 100.45%. The results demonstrated that the excipients in the tablets did not interfere with the method and can be conveniently employed for routine quality control analysis of metformin in bulk and formulation.
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紫外光谱法测定原料药和制剂中二甲双胍的分析方法的建立与验证
建立了一种快速、简便、选择性和精确的紫外可见分光光度法测定盐酸二甲双胍原料药和片剂的含量。以pH 6.8的磷酸盐缓冲液为溶剂,在最大吸收峰为232 nm处进行分光光度检测。验证了该方法的专属性、线性度、准确度、精密度、稳健性和耐用性。在2 ~ 12μg/ml范围内,检测器的响应呈线性,相关系数为0.994。根据回收率研究,准确度在99.1%至100.45%之间。结果表明,片剂中辅料对该方法无干扰,可方便地用于二甲双胍原料药和制剂的常规质量控制分析。
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