Guaifenesin

High Performance Liquid Chromatography (HPLC) Method for Separation of Terbutaline Sulfate, Guaifenesin and Ambroxol on Primesep 200 by SIELC Technologies

Separation type: Liquid Chromatography Mixed-mode

Terbutaline Sulfate is a β₂ analyst typically used as a prescription-strength cough suppressant. Guaifenesin, also known as Glyceryl Guaiacolate, is a popular expectorant used to treat chest congestion. Ambroxol is a well-known expectorant that targets and breaks down phlegm. Together, these three medicinal compounds are typically found as the active ingredients in many cough syrups. They can be retained, analyzed, and separated on a Primesep 200 mixed-mode column using an isocratic analytical method with a simple mobile phase of water, Acetonitrile (MeCN), and a Phosphoric acid (H3PO4) ionic modifier. This analysis method can be detected in the low UV regime at 210 nm.

High Performance Liquid Chromatography (HPLC) Method for Separation of Terbutaline Sulfate, Guaifenesin and Ambroxol

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Condition

Description

Application Notes: Guaifenesin is common, over the counter expectorant. Guaifenesin contain no less than 98 percent and not more than 102 percent of the labeled amount of guaifenesin calculated on a dried basis, according to the USP methods. the The USP HPLC method for the analysis of guaifenesin was developed on our Legacy L1 column according to the US Pharmacopeia methodology. L1 classification is assigned to reversed-phase HPLC column containing C18 ligand. Support for the material is spherical silica gel with particles size 3-10 um and pore size of 100-120A.

Application Columns: Legacy L1 C18 HPLC column

Application compounds: Guaifenesin, benzoic acid

Mobile phase: MeOH/H2O/AcOH 40:60:1.5

Detection technique: UV

Reference: USP 35- NF30

Acetaminophen is an over-the-counter pain and fever reducer, and a major component of cold and flue remedies. Phenylephrine is a decongestant. Guaifenesin is a mucolytic agent used to relieve respiratory difficulties. These three compounds of cough medication were separated by mixed-mode chromatography on a Primesep C HPLC column. Retention and order of elution for phenylephrine can be changed by buffer concentration and buffer pH. Method can be used for analysis of cough and cold composition during the production and in QC/QA environment. Method is compatible with LC/MS and can be used to analyze these components in biological fluids. This generic HPLC method is robust and reproducible.

Method for separation of components of cough medication shows how retention for acetaminophen, phenylephrine and guaifenesin is controlled. Order of elution for compounds can be changed based on composition of the mobile phase. The method is compatible with UV, ELSD and LC/MS and can be used for quantitation of drugs in formulation. Primesep C mixed-mode HPLC column is ideal candidate for analysis of cough compositions. Basic compounds are well retained in mixed-mode chromatography without use of ion-pairing reagents. Several companies validated this approach. The method is reproducible and robust and can be used in both production environments and R&D. This HPLC method can be adopted as general approach for analysis of basic compounds in various mixtures.