新型环保型紫外分光光度法测定托尔伐普坦的方法

Mangesh R Patil, A. Patil, A. Shirkhedkar
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引用次数: 3

摘要

本研究的目的是利用亲水增溶现象,采用零阶紫外分光光度法和零阶曲线下面积(AUC)法,建立简单、经济的紫外分光光度法测定托伐普坦的方法。托伐普坦是非肽抗利尿激素V2受体拮抗剂。它完全不溶于水。采用5% w/v的亲水剂十二烷基硫酸钠(SLS)提高托伐普坦的溶解度。发现Tolvaptan的最大吸收波长为269 nm。在263.2 ~ 282.2 nm波长范围内,采用269 nm吸光度测量和曲线下面积积分法对托伐普坦进行分析。两种方法在3 ~ 18µg/mL范围内呈线性关系,相关系数r2> 0.99。根据ICH指南,验证了所提出的方法的准确性、精密度、可重复性和耐用性。将所提出的方法应用于药物制剂中托伐普坦的定性和定量估计,结果与标签所声称的一致。所建立的方法可用于托伐普坦散装和片剂的常规分析。关键词:十二烷基硫酸钠,托伐普坦,紫外分光光度法-曲线下面积,紫外分光光度法,水性。
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Novel and ecofriendly UV-Spectrophotometry methods for estimation of Tolvaptan using hydrotropic agent
The aim of present investigation is to establish simple and economical UV- Spectrophotometric methods for estimation of Tolvaptan using Zero order UV-Spectrophotometric absorbance method and Zero Order- Area under curve (AUC) method with the application of hydrotropic solubilization phenomenon. Tolvaptan is non-peptide vasopressin V2 receptor antagonist. It is completely insoluble in water. Hydrotropic agent, sodium lauryl Sulfate (SLS) 5% w/v was used to enhance the solubility of Tolvaptan. Maximum absorption for Tolvaptan was found to be at 269 nm. The methods are based upon measurement of absorbance at 269 nm and integration of area under curve for analysis of Tolvaptan in the wavelength range of 263.2-282.2 nm. The drug followed linearity in the concentration range of 3 - 18 µg/mL with correlation coefficient value r2> 0.99 for both methods. The proposed methods were validated for accuracy, precision, repeatability and ruggedness, as per ICH guidelines. The proposed methods were applied for qualitative and quantitative estimation of Tolvaptan in pharmaceutical formulation and results were found in good agreement with the label claimed. Developed methods can be used for routine analysis of Tolvaptan in bulk and tablets. Keywords: Sodium Lauryl Sulphate, Tolvaptan, UV- Spectrophotometry - Area under Curve, UV-Spectrophotometry, Hydrotropy .
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