氢溴酸替尼格列汀有效成分及市售制剂的紫外光谱分析方法验证及定量分析

Kalyani Farkade, M. Tawar
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引用次数: 5

摘要

二肽基肽酶-4抑制剂氢溴替尼格列汀用于降低糖尿病患者的血糖水平。建立了一种简便、快速、灵敏、准确的盐酸替尼格列汀的紫外分光光度分析方法。由于氢溴化物替尼格列汀仅在低波长区域吸收紫外线,因此不能进行高灵敏度的鉴别。氢溴化替尼格列汀仅在牛磺酸和高碘酸钠的排列中显示出成功的结果。原料药是牛磺酸和高碘酸钠在水和甲醇中的衍生物。药物在281nm甲醇中表现出明显的λmax。在10 ~ 80 μg/ml浓度范围内呈线性关系。回收率研究证实了该方法的有效性。所采用的方法价格低廉,对氢溴替尼格列汀原料药和片剂剂型的推断灵敏。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teneligliptin Hydrobromide by UV Spectroscopy
A Dipeptidyl peptidase-4 inhibitor teneligliptin hydrobromide is used for lowering blood glucose levels in people with diabetes mellitus. A very straight forward, quick, responsive and accurate UV- Spectrophotometric method of analysis have been developed for assessment of Teneligliptin Hydrobromide in pharmaceutical formulation. Since teneligliptin hydrobromide only absorbs UV in the low wavelength area, it cannot be identify with high sensitivity. Teneligliptin Hydrobromide has shown successful results for various analytical instruments only in the permutation of Taurine and Sodium periodate. The API was derivatives using Taurine and Sodium periodate in water and methanol. Drug exhibited distinct λmax in methanol at 281nm. Linearity was observed in the concentration range 10-80 μg/ml. The method was validated by recovery studies. The methods used are inexpensive and sensitive for the inference of teneligliptin hydrobromide in bulk drug and tablet dosage forms.
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