SPDS Set 1 ERP Book

CHON-004

Question

Response

General

AOAC Method Number:

CHON-004

Determination of Chondroitin Sulfate Content in Raw Materials and Dietary Supplements by High-Performance Liquid Chromatography with Ultraviolet Detection After Enzymatic Hydrolysis

Method Title:

Method Author(s):

David Ji, Mark Roman, Joseph Zhou, and Jana Hildreth

Reviewer Name:

Darryl Sullivan

This method measures chondroitin sulfate after hydrolysis with chondroitinase ACII enzyme that form un-, mono-, di-, and trisulfated unsaturated disaccharides. The resulting disaccharides are quantified using ion-pairing liquid chromatography with UV detection at 240 nm. The quantities of the individual disaccharides are summed to yield the total amount of chondroitin sulfate in the test samples. This method is applicable to the determination of chondroitin sulfate in raw materials, and finished products. It has been studied on capsules, dietary supplement tablets, softgels, and liquids. The method has been through a single laboratory validation and has been well studied. This method is clearly written, and easy to follow and understand. This method offers a way to measure chondroitin sulfate through the quantification of the component disaccharides. The method has been exposed to a significant amount of validation. The published method performance for repeatability precision, and accuracy are good. This method utilizes a very specific enzyme and requires the use of some unusual disaccharide standards. Supporting Data

Summary of Method

Method Scope / Applicability:

General Comments About the Method:

Method Clarity

Pros/Strengths

Cons/Weaknesses

General Comments

This method has been used successfully and demonstrates