Validation of a non-official analysis method for a granulated product based on glucosamine and chondroitin

Abstract

Abstract: Introduction: Glucosamine and chondroitin are structural constituents of the extracellular matrix of articular cartilage; they provide the cartilage with its mechanical and elastic properties for its ability to retain water. These are widely used today for the treatment of osteoarthritis worldwide and are classified as Symptomatic Slow Action Drugs for Osteoarthritis (SYSADOA). Objective: To develop and validate a non-official method of analysis for the assay of a product based on glucosamine and chondroitin in the form of granules. Method: A High-resolution liquid chromatography (HPLC) method was developed and validated, emphasizing that there is currently no other official HPLC method for the analysis of these active ingredients. The procedure used a C18 chromatographic column at a mobile phase flow of 1 mL / min and using an injection volume of 10 μL. The active ingredients of the analyzed product are in the form of sodium hydrochloride for glucosamine and sodium sulfate for chondroitin. Results: The results obtained for the analysis of each validation performance parameter met the established acceptance criteria. Conclusions: By accepting each of the performance parameters for the developed method, it can be concluded that it is duly validated and can be reliably used.