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用于测定原料药及制剂中西他列汀和维格列汀的分光光度法。

Spectrophotometric methods for the determination of sitagliptin and vildagliptin in bulk and dosage forms.

作者信息

El-Bagary Ramzia I, Elkady Ehab F, Ayoub Bassam M

机构信息

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, Egypt.

出版信息

Int J Biomed Sci. 2011 Mar;7(1):55-61.

Abstract

Simple, accurate and precise spectrophotometric methods have been developed for the determination of sitagliptin and vildagliptin in bulk and dosage forms. The proposed methods are based on the charge transfer complexes of sitagliptin phosphate and vildagliptin with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ), 7,7,8,8-tetracyanoquinodimethane (TCNQ) and tetrachloro-1,4-benzoquinone (p-chloranil). All the variables were studied to optimize the reactions conditions. For sitagliptin, Beer's law was obeyed in the concentration ranges of 50-300 μg/ml, 20-120 μg/ml and 100-900 μg/ml with DDQ, TCNQ and p-chloranil, respectively. For vildagliptin, Beer's law was obeyed in the concentration ranges of 50-300 μg/ml, 10-85 μg/ml and 50-350 μg/ml with DDQ, TCNQ and p-chloranil, respectively. The developed methods were validated and proved to be specific and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

摘要

已开发出简单、准确且精密的分光光度法,用于测定原料药及剂型中的西他列汀和维格列汀。所提出的方法基于磷酸西他列汀和维格列汀与2,3 - 二氯 - 5,6 - 二氰基 - 1,4 - 苯醌(DDQ)、7,7,8,8 - 四氰基对苯二醌二甲烷(TCNQ)和四氯 - 1,4 - 苯醌(对苯醌)形成的电荷转移络合物。研究了所有变量以优化反应条件。对于西他列汀,分别与DDQ、TCNQ和对苯醌在50 - 300μg/ml、20 - 120μg/ml和100 - 900μg/ml的浓度范围内符合比尔定律。对于维格列汀,分别与DDQ、TCNQ和对苯醌在50 - 300μg/ml、10 - 85μg/ml和50 - 350μg/ml的浓度范围内符合比尔定律。所开发的方法经过验证,证明对药物剂型中所述药物的质量控制具有特异性和准确性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a855/3614814/0280921f9b9e/IJBS-7-55_F1.jpg

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