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验证不同分光光度法测定二元混合物中维格列汀和二甲双胍的方法。

Validation of different spectrophotometric methods for determination of vildagliptin and metformin in binary mixture.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2014 May 5;125:175-82. doi: 10.1016/j.saa.2014.01.055. Epub 2014 Jan 31.

DOI:10.1016/j.saa.2014.01.055
PMID:24548810
Abstract

New, simple, specific, accurate, precise and reproducible spectrophotometric methods have been developed and subsequently validated for determination of vildagliptin (VLG) and metformin (MET) in binary mixture. Zero order spectrophotometric method was the first method used for determination of MET in the range of 2-12 μg mL(-1) by measuring the absorbance at 237.6 nm. The second method was derivative spectrophotometric technique; utilized for determination of MET at 247.4 nm, in the range of 1-12 μg mL(-1). Derivative ratio spectrophotometric method was the third technique; used for determination of VLG in the range of 4-24 μg mL(-1) at 265.8 nm. Fourth and fifth methods adopted for determination of VLG in the range of 4-24 μg mL(-1); were ratio subtraction and mean centering spectrophotometric methods, respectively. All the results were statistically compared with the reported methods, using one-way analysis of variance (ANOVA). The developed methods were satisfactorily applied to analysis of the investigated drugs and proved to be specific and accurate for quality control of them in pharmaceutical dosage forms.

摘要

已开发并随后验证了新的、简单的、特定的、准确的、精确的和可重现的分光光度法,用于二元混合物中维格列汀(VLG)和二甲双胍(MET)的测定。零阶分光光度法是第一种用于测定 MET 的方法,其测定范围为 2-12μg/mL,测定波长为 237.6nm。第二种方法是导数分光光度技术,用于测定 1-12μg/mL 范围内的 MET,测定波长为 247.4nm。导数比分光光度法是第三种技术,用于测定 4-24μg/mL 范围内的 VLG,测定波长为 265.8nm。第四和第五种方法用于测定 4-24μg/mL 范围内的 VLG,分别为比值减法和均值中心化分光光度法。所有结果均与报道的方法进行了统计学比较,采用单向方差分析(ANOVA)。所开发的方法可满意地应用于所研究药物的分析,并证明在药物制剂中对其质量控制具有特异性和准确性。

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