硅学改良紫外分光光度法解决重叠光谱问题,用于罗伐他汀和替尼列汀制剂的质量控制

IF 1.8 4区 物理与天体物理 Q2 PHYSICS, MULTIDISCIPLINARY Open Physics Pub Date : 2024-04-18 DOI:10.1515/phys-2024-0014
Mahesh Attimarad, Katharigatta Narayanaswamy Venugopala, Anroop B. Nair, Bandar Aldhubiab, Sreeharsha Nagaraja
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引用次数: 0

摘要

用于治疗心血管并发症的罗伐他汀(ROS)和替尼列汀(TEN)二元混合物需要一种简单的分析方法来保证制剂的质量。ROS 和 TEN 的紫外线吸收光谱显示出重叠的光谱。因此,ROS 和 TEN 的重叠光谱通过比值差法、比值一阶导数法、常数提取与指数除谱法以及诱导双波长法进行了分离。根据国际协调委员会的标准,对所提出的方法进行了认证。所有四种方法都显示出良好的线性关系,ROS 和 TEN 的线性范围分别为 2-15 µg/mL 和 2-30 µg/mL。ROS 和 TEN 的检索率分别为 98.96-100.22% 和 98.72-99.73%,相对误差较小,这保证了技术的正确性。经过验证的技术被用于同时评估二元配方和实验室制备混合物中的 ROS 和 TEN。标准添加过程验证了预计程序的可靠性。与 HPLC 方法和更安全的溶剂相比,所开发的方法显示出相同的准确度和精确度。最后,发现所提出的紫外光谱程序的环境可持续性优于所报告的高效液相色谱法。因此,在常规质量控制研究中,可以采用环保、简单、准确的数学处理紫外光谱程序来同时定量 ROS 和 TEN。
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In silico modified UV spectrophotometric approaches to resolve overlapped spectra for quality control of rosuvastatin and teneligliptin formulation
A binary blend of rosuvastatin (ROS) and teneligliptin (TEN) used for the management of cardiovascular complications require a simple, analytical process for the quality assurance of this formulation. UV absorption spectra of ROS and TEN showed overlapping spectra. Hence, the overlapped spectra of ROS and TEN were separated by ratio difference, ratio first derivative; constant extraction coupled with exponentiation with division spectrum, and induced dual-wavelength methods. The proposed methods were authenticated by following the international council for harmonization criteria. A good linear relationship was demonstrated by all four methods, in 2–15 and 2–30 µg/mL for ROS and TEN, respectively. The high percentage retrieval of 98.96–100.22 and 98.72–99.73% for ROS and TEN, respectively, with small relative error, assured the correctness of the techniques. The validated techniques were employed for concurrent evaluation of ROS and TEN from binary formulation and laboratory-prepared mixture. The standard addition process verified the reliability of the projected procedures. The developed methods showed same accuracy and precision when compared to the HPLC methods along with safer solvent. Finally, the environmental sustainability of the presented UV spectroscopic procedures was found to be better than the reported HPLC method. Hence, eco-friendly, simple, and accurate mathematically processed UV spectroscopic procedures can be employed for simultaneous quantification of ROS and TEN for routine quality control study.
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来源期刊
Open Physics
Open Physics PHYSICS, MULTIDISCIPLINARY-
CiteScore
3.20
自引率
5.30%
发文量
82
审稿时长
18 weeks
期刊介绍: Open Physics is a peer-reviewed, open access, electronic journal devoted to the publication of fundamental research results in all fields of physics. The journal provides the readers with free, instant, and permanent access to all content worldwide; and the authors with extensive promotion of published articles, long-time preservation, language-correction services, no space constraints and immediate publication. Our standard policy requires each paper to be reviewed by at least two Referees and the peer-review process is single-blind.
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