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Analytical chemistry applied to pharmaceuticals development: A study of drug product degradation and a study of the analysis of chiral pharmaceuticals.

机译：分析化学应用于药物开发：药物降解研究和手性药物分析研究。

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摘要

Analytical chemistry plays a key role in the development, manufacturing and approval of pharmaceutical products. Pharmaceuticals are a highly regulated industry, consequently; two areas of analytical interest for Food and Drug Administration are analytical methods for compounded products and quantitation of enantiomeric purity of chiral drug substances.; Part I of this research focused on the evaluation of Benzamycin RTM, a compounded drug product. Compounded drug products, though evaluated, are not subjected to the level of scrutiny that is involved in traditional drugs. A danger of compounded products is that one does not know the final potency, which is based on the pharmacist mixing technique. The product was evaluated so as to determine the formulation. Research was mainly devoted to the development and validation of a stability indicating method for not only the active Benzoyl Peroxide, but also the related substances, benzoic acid, benzaldehyde and ethyl benzoate. The new combined rugged method was compared to compendial methods and found to be more accurate and sensitive. Predictions of degradation pathways were proposed. Forced degradation studies confirmed that the method was stability indicating.; Part II of the research was devoted to new methods for evaluating enantiomeric purity. It is known that enantiomers may have differences in biological efficacy and activity, thus it is imperative to know the quantities of each isomer present. The objective was to evaluate the purity of chiral drugs via a chiral separation method and a chiral detection method. Ketoprofen, Ibuprofen and Flurbiprofen were studied and a new reversed phase chiral HPLC method was developed. Additionally, circular dichroism was employed to evaluate purity. It has been concluded that not only are reversed phased chiral separation methods accurate, but also that an achiral method combined with circular dichroism detection can also evaluate purity. Enantiomeric excess values from CD detection were comparable to UV and fluorescence. Finally, it is recommended that the g-factor be used in determining chiral purity of drugs.; This research details some analytical barriers that pharmaceutical chemists encounter. Accomplishing theses goals exhibits success of new technologies and demonstrates the need to continually advance in analytical chemistry.
机译：分析化学在药物产品的开发，制造和批准中起着关键作用。因此，制药业是一个受到严格管制的行业。食品和药物管理局的两个分析领域是复合产品的分析方法和手性药物对映体纯度的定量。这项研究的第一部分着重于复合药物Benzamycin RTM的评估。尽管对复合药物产品进行了评估，但并未受到传统药物所涉及的详细审查。混合产品的危险是基于药剂师的混合技术，不知道最终的效力。评价产物以确定制剂。研究主要致力于开发和验证不仅用于活性过氧化苯甲酰，而且用于相关物质苯甲酸，苯甲醛和苯甲酸乙酯的稳定性指示方法。将新的结合的坚固耐用方法与药典方法进行比较，发现它更加准确和敏感。提出了降解途径的预测。强迫降解研究证实了该方法的稳定性。研究的第二部分致力于评估对映体纯度的新方法。已知对映异构体在生物学功效和活性上可能具有差异，因此必须知道存在的每种异构体的量。目的是通过手性分离方法和手性检测方法评估手性药物的纯度。研究了酮洛芬，布洛芬和氟比洛芬，并开发了一种新的反相手性HPLC方法。另外，采用圆二色性评估纯度。已经得出结论，不仅反相手性分离方法准确，而且非手性方法与圆二色性检测相结​​合也可以评估纯度。 CD检测的对映体过量值与UV和荧光相当。最后，建议将g因子用于确定药物的手性纯度。这项研究详细介绍了药物化学家遇到的一些分析障碍。这些目标的实现展示了新技术的成功，并表明了在分析化学领域不断发展的需要。

著录项

  • 作者

    Ciliberto, Cynthia Marie.;

  • 作者单位

    Temple University.;

  • 授予单位 Temple University.;
  • 学科 Chemistry Analytical.; Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2004
  • 页码 353 p.
  • 总页数 353
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 化学;药剂学;
  • 关键词

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