Abstract
This chapter will address the importance of the application of high-performance liquid chromatography (HPLC) to carry out, optimally and efficiently, the quality control of pharmaceutical products (capsules, tablets, nanoformulations) and medical devices. This instrumental method has a high application in the validation and verification of pharmacopoeia analytical methods, thus complying with the different parameters of the current regulations. Likewise, it will be sought to understand and interpret each of the chromatographic parameters and achieve solutions to possible inherent obstacles that may arise when applying the technique.
Top1. Introduction
Chromatography is the analytical technique for the separation of compounds or solutes, which are distributed in a fluid phase, called the mobile phase, which elutes through a stationary phase. The mobile phase can be in liquid or gas form, while the stationary phase can be in solid or liquid form. Over the years, this technique has been developed and applied to different areas and in different ways.
There is an advanced technique derived from elution chromatography called high-performance liquid chromatography (HPLC), a technique in which a liquid (mobile phase) is in contact with a solid (stationary phase). Likewise, it is constituted by a mixture of analytes that advance together with the mobile phase through the stationary phase; these analytes will be observed at different times, depending on the affinity they have with the stationary phase (column), i.e., these analytes will separate. This technique is useful for quantitative and qualitative analysis.
In this chapter, we will focus on the use and application of the HPLC technique in the pharmaceutical industry and its relation to sanitary regulation, to give a general, but punctual overview of everything that can and should be done in the pharmaceutical sector when using HPLC.
Key Terms in this Chapter
Nanosystems: Formulation with nanometer-scale sizing.
HPLC: High-performance liquid chromatography, a chromatographic technique used to analyze molecules qualitatively and quantitatively.
Chromatographic Conditions: Set of factors that influence the development of a chromatographic method.
Chromatography: Refers to the separation of compounds, which can be done by different techniques. For example, liquid chromatography.
Drug Analysis: Set of techniques that allow the analysis and characterization of drugs.
Pharmacopeia: A book containing information on different drugs and their methods of analysis.
Validation: The process of ensuring that the performance characteristics of an analytical method are reproducible.
Pharmaceutical Industry: Company dedicated to the development, preparation, and commercialization of products of pharmaceutical interest.
Chromatographic Parameters: Set of values obtained from a chromatogram that describes the separation of a compound.
Pharmaceutical Analysis: A set of techniques developed in the pharmaceutical industry and laboratories for the analysis of substances of pharmaceutical interest.