商业药物配方中亲水溶液的生态友好型统计化学计量辅助分光光度和色谱模型开发

IF 1.3 4区 化学 Q4 BIOCHEMICAL RESEARCH METHODS
Pritam S. Jain, Deepak M. Patil
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引用次数: 0

摘要

Oflox-TZ, Dto和Ofnida糖浆是众所周知的抗菌组合药物,用于治疗由寄生虫和细菌引起的疾病。利用化学计量学应用、等吸点和双波长辅助的分光光度法和色谱分析,利用方差分析与所有已开发的方法进行比较,建立环境可持续的抗菌化合物模型。使用偏最小二乘法对光谱重叠和有机溶剂在分光光度和色谱条件下的有害使用进行反卷积,使用或不使用变量选择方法,如主成分回归。当将开发方法的结果与方差分析进行统计比较时,发现了良好的一致性,表明建议方法的有效性。采用部分析因设计,为不同剂量的实验精心建立了分别由24个和12个样品组成的校准和验证集。根据已建立的国际协调理事会(ICH)战略对开发的模型进行了验证。对于双波长方法,Beer 's图证实了(OFL)和替硝唑(TZ)分别在2和12µg/mL和5和30µg/mL之间的线性关系。OFL和TZ的平均回收率分别为101.0%和102.0%。化学计量学辅助紫外分光光度法,采用偏最小二乘(PLS)和主成分回归(PCR)分析模型,得到OFL的平均回收率为102.3% (PLS)和102.4% (PCR), TZ的平均回收率为102.6% (PLS)和102.6% (PCR)。此外,使用亲水溶液开发的色谱模型在商业药物配方中对OFL和TZ的平均回收率分别为100.2%和100.6%。研究发现,所提出的化学计量辅助分光光度法和色谱法可以可靠地测定实验室制备的混合物和药物制剂中的OFL和TZ浓度,从而证明它们是有效的分析工具,用于不同药物制剂的质量控制和过程测试。这种方法比使用污染较少的溶剂提供了显著的结果,使其更加精确和经济。图形抽象
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Eco-friendly Statistical Chemometric-Assisted Spectrophotometric and Chromatographic Model Development in Hydrotropic Solutions for Commercial Drug Formulations

Eco-friendly Statistical Chemometric-Assisted Spectrophotometric and Chromatographic Model Development in Hydrotropic Solutions for Commercial Drug Formulations

Oflox-TZ, Dto, and Ofnida syrup are well-known antimicrobial combination medications used to treat illnesses caused by parasites and bacteria. Environmentally sustainable model creation for antimicrobial compounds utilizing chemometric application, isosbestic point, and dual wavelength assisted by spectrophotometric and chromatographic analysis using ANOVA comparison with all developed methods. Deconvolution of the spectral overlaps and harmful use of organic solvents in spectrophotometric and chromatographic conditions with these combinations were performed using the partial least squares method, either with or without variable selection methods such as principal component regression. A good agreement was found when comparing the findings of the developed methods statistically to an ANOVA, indicating the efficacy of the suggested methodology. Calibration and validation sets comprising 24 and 12 samples, respectively, were carefully developed using partially factorial designs for the experiments at different dosages. The developed models were validated according to established International Council for Harmonisation (ICH) strategies. For the dual-wavelength approach, Beer’s plot confirmed linearity between 2 and 12 µg/mL for (OFL) and 5 and 30 µg/mL for Tinidazole (TZ) respectively. The mean percent recoveries were found to 101.0% and 102.0% for OFL and TZ. Chemometrics-assisted UV spectrophotometry, employing both partial least squares (PLS) and principal component regression (PCR) analysis models, yielded mean OFL recoveries of 102.3% (PLS) and 102.4% (PCR), and TZ recoveries of 102.6% (PLS) and 102.6% (PCR). Additionally, chromatographic model development using hydrotropic solutions yielded mean percentage recoveries of 100.2% and 100.6% for OFL and TZ, respectively, in commercial drug formulations. The study found that the proposed chemometric-assisted spectrophotometric and chromatographic methods could reliably determine OFL and TZ concentrations in both laboratory-prepared mixtures and pharmaceutical preparations, thereby proving them to be useful analytical instruments for quality control and in-process testing of different pharmaceutical drug preparations. This approach provides a significant outcome over the use of less polluted solvents, making it more precise and economical.

Graphical Abstract

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来源期刊
Chromatographia
Chromatographia 化学-分析化学
CiteScore
3.40
自引率
5.90%
发文量
103
审稿时长
2.2 months
期刊介绍: Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.
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