同时测定尼群地平和氢氯噻嗪的紫外光谱吸收比法的建立和验证

A. Soni, Muskan Sharma, C. Kumari
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引用次数: 0

摘要

成功开发并验证了一种新的紫外光谱法同时测定片剂中尼群地平和氢氯噻嗪的含量,该方法具有新颖、简便、准确、精密、线性和灵敏度等特点,采用对零阶吸收光谱内的同位点的分析。具体而言,采用282nm波长的等吸收点测定尼群地平和氢氯噻嗪。使用吸光度因子计算每种化合物在282nm的等吸收点处的吸光度,该吸光度因子导出为利用282nm的同吸收点的各种浓度的纯尼群地平的平均吸光度。随后,根据国际人类药物技术要求协调理事会(ICH)制定的指南,对开发的方法进行了全面的验证。线性范围是基于它们在282nm的等吸收点处各自的λmax来确定的。这些结果的结果表明,本研究具有新颖性、准确性、有效性、精密性、快速性、再现性、简单性和敏感性。因此,所提出的方法被认为适用于成功估算片剂剂型中尼群地平和氢氯噻嗪的含量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of a UV Spectroscopy Absorption Ratio Method for Simultaneous Estimation of Nitrendipine and Hydrochlorothiazide
A novel UV-spectroscopic method, characterized by its novelty, simplicity, accuracy, precision, linearity, and sensitivity, has been successfully developed and validated for the simultaneous estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form. The method relied on the absorption factor approach, employing the analysis of isosbestic points within the zero-order absorption spectra. Specifically, the isoabsorptive points at a wavelength of 282 nm were employed for the determination of Nitrendipine and Hydrochlorothiazide. The absorbance corresponding to each compound at the isoabsorptive point of 282 nm was calculated using the absorbance factor, derived as the average absorbance of various concentrations of pure Nitrendipine utilizing the isoabsorptive point at 282 nm. Subsequently, the developed method underwent a comprehensive validation process, adhering to the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The linearity range was determined based on their respective λ max at the isoabsorptive point of 282 nm. The culmination of these results leads to the conclusion that the present research is characterized by novelty, accuracy, efficiency, precision, rapidity, reproducibility, simplicity, and sensitivity. Consequently, the proposed method is deemed suitable for the successful estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form.
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