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The precision, ease of use, and ruggedness of HPLC methods are preferred by far over other separation and quantification techniques. A continuous effort to learn updated technology and to remain informed of constantly changing regulations is the only way to succeed in the pharmaceutical industry. XIV. IMPURITY EVALUATIONS Impurities in drug substances and drug products continue to be the source of great concern, discussion, debate, and research (see Chapter 14). These concerns and debates typically center on the potential safety risks associated with impurities resulting from contamination.

5 btm or 12,000 plates. 5~m or 20,000 plates. For this reason, columns packed with smaller particles are usually more efficient. E. Resolution (Rs) The goal of most HPLC analysis is the separation of one or more analytes from other components in the sample in order to obtain quantitative information for each analyte. Resolution (R~) is the degree of separation of two adjacent analyte peaks, and is defined as the difference in retention times of the two peaks divided by the average peak width (Figure 6).

C. Some HPLC Axioms II. FUNDAMENTAL CONCEPTS A. Retention B. Capacity Factor (k') C. Selectivity (~) D. Column Efficiency (N) E. Resolution (Rs) E Tailing Factor (Tf) G. The Resolution Equation H. The van Deemter Equation III. MOBILE PHASE PARAMETERS A. Organic Solvent Strength and Selectivity B. Buffers C. Acidic Mobile Phase D. Ion-pairing Reagents E. High pH Mobile Phase F. Other Parameters (Flow rate [F], Column Temperature [T]) IV. ISOCRATIC VS. GRADIENT ANALYSIS A. Key Gradient Parameters (Flow Rate, Gradient Time [tG], Peak Capacity [P]) V.

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