Ion chromatography – The all-rounder for pharmaceutical analysis

Ion chromatography – The all-rounder for pharmaceutical analysis

Overview

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  • Source: Metrohm India Private Limited

  • Date: 05 Jun,2022

Ion chromatography (IC) is the method of choice to determine active pharmaceutical ingredients, excipients, and traces of impurities and metabolites in the form of organic and inorganic ions or polar substances in a number of pharmaceuticals, pharmaceutical solutions, or even body fluids.

Ion chromatography can determine chemically similar substances within a very short time in a single analysis. The concentration of the analytes can vary from ng/L up to the percent range. Another advantage is the large selection of separation columns and elution systems available. Interfering matrix effects can be avoided by using a suitable inline sample preparation method or through the choice of the detection method:

1.Conductivity detection with and without suppression

2.Electrochemical or amperometric detection

3.Spectrophotometric detection with and without post-column derivatization (UV/VIS)

4.Coupled detection methods such as IC-MSand IC-ICP/MS

The intelligent ion chromatographs, automation devices, and peripheral equipment are controlled by the user-friendly software MagIC Net. Complete documentation on the state of the analysers and user activities provides complete traceability of the analysis results. MagIC Net fully supports FDA regulation 21 CFR Part 11 and offers a large number of tools for compliance with the GLP guidelines.

Determinations that can be done using Ion Chromatography

1.Anions

2.Cations

3.Transition metals including lanthanides, uranium, thorium

4.Speciation – arsenic, chromium, iron, platinum, selenium

5.Organic acids and fatty acids

6.Carbohydrates – mono, di, oligo, polysaccharides.

7.Aliphatic and biogenic amines

8.Amino acid

Pharmacopoeias and drug safety

According to the World Health Organization (WHO), standards and test procedures for frequently used active components and excipients are detailed in monographs published in more than 38 nations’ national pharmacopoeias.

These include the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph.Eur.), derived from harmonization of the regulations of a number of individual states, and the Japanese Pharmacopoeia (JP), to name just a few examples.

The pharmacopoeias are official compendia containing statutory requirements pertaining to identity, content, quality, assay, impurities, packaging, storage, and labeling of active pharmaceutical ingredients and other products used for therapeutic purposes. They are essential for anyone seeking to produce, test, or market medicinal products.

Pharmaceutical solutions

The term pharmaceutical solutions denotesisotonic solutions, hemodialysis solutions, or infusion solutions. They contain anions, cations, carbohydrates, and organic acids, the concentrations of which frequently differ from one another by several orders of magnitude.

Within the context of production monitoring and final quality control these ingredients need to be determined easily, quickly, and with a high degree of precision.

Ion chromatography, with its intelligent analytical procedure and automatic inline sample preparation fully accomplishes this task.”

Active Pharmaceutical ingredients

Active pharmaceutical ingredients in tablets such as gentamicin, neomycin, cefadroxil, or bethanechol chloride can be determined by ion chromatography in accordance with the regulations of the U.S. Pharmacopeiand Europeanan Pharmacopoeia.

The requirements regarding precision, separation, and recovery of the analytes are described in detail in the pharmacopoeiass.

Impurities in pharmaceuticals

In addition to active pharmaceutical ingredient analysis, ion chromatography can also be used to determine impurities in pharmaceutical products. Even small concentrations of an impurity can cause significant side effects. For example, the recent discovery of the presence of nitrosamines impurities in drugs. Scientists across the industry are looking for the determination of nitrite in pharmaceuticals to assess the possibility of the formation of nitrosamines using ion chromatography with a UV detector.

The nitrite determination is more selective, more sensitive, and most importantly – faster – when using Inline Matrix Elimination, whereby the interfering pharmaceutical matrix is already separated from the target analyte during the sample preparation step.

Quality control of Vaccines

As vaccines are medical products for human use, they require rigorous characterization, and assays to ensure final product quality and consistency.

For glycoconjugate vaccines, it is important to measure both free and total polysaccharides to ensure their quality. The proportion of unconjugated polysaccharides must be monitored as the presence of a large number of unconjugated polysaccharides may suppress immunity to the antigen.

Additionally, the presence of free polysaccharides is a key indicator of process consistency and is an indirect measure of the covalent attachment to the carrier.

The polysaccharide concentration must be confirmed as it is directly related to the product quality. High-performance anion-exchange chromatography with pulsed amperometric detection (PAD)easily separates and detects carbohydrates without the need for analyte derivatization. This is one of the biggest advantages of the technique.

Cleaning Validation

Cleaning validation is the procedure used to ensure that the cleaning process has eliminated the residues of drug substance from on the equipment surface after manufacture. Ion Chromatography technique can be used for such studies to ensure that the equipment is qualified.

About Metrohm

Metrohm India Private Limited is a total analytical solution provider, serving the Indian market for more than 2 decades. We are immensely proud to have all the major companies from the public and private sectors, spanning across almost all the industries, as our customers. Our operations cover all the zones in the country with 11 main offices coupled with 7 resident offices at remote locations. All the offices are well-equipped with best-in-class infrastructure to support training, demonstrations, and meetings. We also have our application laboratory in Chennai, with dedicated sections for major techniques to serve our customers with application support, method development, and technical training. Our team of professionals also caters to the training needs of customers, apart from the application support.

For more information contact us at: info@metrohm.in or visit our website: https://www.metrohm.com/en_in.html

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