评估制药研发中精确定量四种抗病毒药物的分析技术:全面回顾

Akhil Gupta, Shilpi Pathak
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摘要

:在制药研究中,精确测量药物浓度至关重要,尤其是对于抗病毒药物,如博西瑞韦、埃维特拉韦、茚地那韦和沙奎那韦等抗病毒药物。众所周知,分析技术在鉴定和表征生物样本和药物制剂中的活性药物成分方面发挥着至关重要的作用。此外,精确的药物评估直接影响药物的安全性、稳定性和有效性,同时还能深入了解药物的药代动力学。除此之外,分析技术还有助于识别杂质、变质产品和潜在污染物。因此,可靠的分析方法已成为应对复杂药物制剂挑战的关键。最常用的分析技术是紫外分光光度法,这种方法灵敏度不高,无法检测复杂的药物制剂。相比之下,液相色谱-质谱法/质谱法(LC-MS/MS)融合了色谱法和质谱法两种分析技术,可对生物样本进行精确定量。此外,与高效液相色谱法相比,超高效液相色谱法(UPLC)的分辨率更高、分析时间更短、溶剂消耗更少。本综述旨在严格评估每种分析方法的准确性、适用性、选择性和局限性,从而为研究人员和分析人员提供有价值的见解。了解这些分析技术的优缺点后,研究人员就能根据自己的需要和要求选择合适的分析方法,以进行质量评估、精确药物定量和优化治疗效率。最终,本综述旨在通过确保有效、安全地使用疗法,推动药物研发,特别是抗病毒药物的研发。
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Assessment of Analytical Techniques for Precise Quantification of Four Antiviral Drugs in Pharmaceutical Research and Development: A Comprehensive Review
: Precise measurement of drug concentration in pharmaceutical research is critical, especially for anti-viral drugs like boceprevir, elvitegravir, indinavir, and saquinavir that combat viral infections. It is well-known that analytical techniques play an imperative role in identifying and characterizing active pharmaceutical ingredients in biological samples and drug formulations. Moreover, precise drug assessment directly influences safety, stability, and efficacy while providing in-depth insight into drug pharmacokinetics. Other than this, analytical techniques also aid in identifying impurities, deteriorated products, and potential pollutants. Thus, reliable analytical methods have become crucial for addressing challenges imposed by complex drug formulations. The most commonly used analytical technique is UV spectrophotometry, which does not have the high sensitivity to detect complex drug formulations. In contrast, Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) merges two analytical techniques, chromatography and mass spectrometry, to accurately quantify biological samples. Furthermore, Ultra-Performance Liquid Chromatography (UPLC) provides enhanced resolution, faster analysis in short duration, and low solvent consumption in contrast to HPLC. This comprehensive review aims to critically assess each analytical approach's accuracy, applicability, selectivity, and limitation to provide valuable insights for researchers and analysts. Understanding the weaknesses and strengths of these analytical techniques will enable the researchers to select the suitable analytical method based on their needs and requirements for quality assessment, precise drug quantification, and optimal therapeutic efficiency. Eventually, this review intends to advance pharmaceutical research and development, specifically for anti-viral drugs, by ensuring the effective and secure administration of therapies.
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