TAILIEUCHUNG - HPLC for Pharmaceutical Scientists 2007 (Part 8A)

The primary focus of this chapter in on general approaches and considerations toward development of high-performance liquid chromatography (HPLC) methods for separation of pharmaceutical compounds, which may be applied within the various functions in the drug development continuum. It is very important to understand the aim of analysis and the requirements for a particular method to be developed. The aim of analysis of each HPLC method may vary for each developmental area in the drug development process and specific examples are given in Section . General method development considerations that apply to all reversedphase methods are discussed in Section. | 8 METHOD DEVELOPMENT Rosario LoBrutto INTRODUCTION The primary focus of this chapter in on general approaches and considerations toward development of high-performance liquid chromatography HPLC methods for separation of pharmaceutical compounds which may be applied within the various functions in the drug development continuum. It is very important to understand the aim of analysis and the requirements for a particular method to be developed. The aim of analysis of each HPLC method may vary for each developmental area in the drug development process and specific examples are given in Section . General method development considerations that apply to all reversed-phase methods are discussed in Section . These include properties of the analyte detector mobile phase stationary phase and gradient considerations. Building upon this knowledge strategies for method development for target analytes in which the structure is known and not known are given as general guidelines. This material is reinforced with several method development case studies emphasizing the approaches used and the shortcomings that were encountered during the method development continuum. Also a method development flow chart for gradient separations is provided in Section Figure 8-37 which can be used as an excellent starting point for the development of HPLC methods. Also throughout this chapter we focus on analytical challenges a pharmaceutical scientist encounters during method development these include speed HPLC for Pharmaceutical Scientists Edited by Yuri Kazakevich and Rosario LoBrutto Copyright 2007 by John Wiley Sons Inc. 347 348 METHOD DEVELOPMENT of separation sample preparation extraction issues solution stability detection sensitivity effect of pH and separations for structurally similar species. The final part of the chapter provides a refresher on pKa from an analytical chemist s perspective the drivers for choosing normal phase versus reversed phase as a separation mode

• Y học thường thức
• method development
• HPLC
• Pharmaceutical Scientists 2007
• HPLC Theory
• tài liệu chuyên ngành dược
• sách học dược sĩ
• A first course in the finite element method
• The finite element method
• Introduction to the stiffness method
• Development of truss equations
• Development of beam equations
• The plane stress
• Analysis of economic development of Ukraine regions based on taxonomy method
• Analysis of economic development
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• Regional economic development level
• Vietnam Journal of Science and Technology
• Development of spectrophotometric method
• Development of spectrophotometric method for determination of ceftazidime
• Marshall reagent in pharmaceutical preparation
• Bratton Marshall reagent
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• Lecture Finite element method
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• A quality index method
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