Development of UV-Visible spectrophotometric method for the estimation of vildagliptin in different medium

Sheetal Sheetal Mane, M. Khan
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Abstract

A simple, accurate, precise, cost effective, rapid and sensitive UV/visible spectrophotometric method was developed for the determination of Vildagliptin in active pharmaceutical dosage form. The developed method was validated as per ICH guidelines.The purity of Vildagliptin was characterized by melting point, Fourier Transform Infra-Red and DSC. The drug was analyzed using UV/visible spectrophotometric method was validated in terms of linearity and range. The solvents used was water, 0.1 N HCl and phosphate buffer pH 7.4 and the wavelength corresponding to maximum absorbance of the drug were found at 210 nm.Melting point of drug was found 151.67°C nearly corresponds to its actual melting range. The linear response for concentration range of 2-12 µg/ml of vildagliptin for water, 0.1 N HCl and phosphate buffer pH 7.4 was recorded each with regression coefficient R = 0.9998, 0.9994 and 0.9991 respectively.The drug was confirmed by interpretation of UV spectra. Hence, proposed method stands out validated and shows a linear relationship and thus may be used for routine analysis of Vildagliptin in pharmaceutical dosage forms.
紫外可见分光光度法测定维格列汀在不同介质中的含量
建立了一种简便、准确、精密度高、成本效益好、快速灵敏的紫外/可见分光光度法测定活性制剂维格列汀含量的方法。所开发的方法按照ICH指南进行了验证。用熔点、傅里叶变换红外光谱和差示量热分析对维格列汀的纯度进行了表征。采用紫外/可见分光光度法对药物进行分析,并在线性和范围上进行了验证。溶剂为水、0.1 N HCl和pH 7.4的磷酸盐缓冲液,药物最大吸光度对应的波长为210 nm。熔点151.67℃与药物的实际熔点基本一致。维格列汀在2 ~ 12µg/ml的浓度范围内对水、0.1 N HCl和pH 7.4的磷酸盐缓冲液均有线性响应,回归系数R分别为0.9998、0.9994和0.9991。通过紫外光谱分析证实了该药物的药性。因此,所提出的方法经过验证并显示出线性关系,因此可用于药物剂型中维格列汀的常规分析。
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