Glucosamine HCl which is the active pharmaceutical ingredient (API) of interest in glucosamine tablets was analyzed by HPLC following dissolution testing to determine the concentration of the API that was dissolved in the dissolution media. The test parameters and procedure for this analysis were obtained from the monograph for glucosamine tablets found under the dietary supplement section of the USP. The listed Q value for Glucosamine tablets is that not less than 75% of the labeled amount is dissolved in 60 minutes. Figures of merit for this HPLC method were determined using a carbon chain (C18)-bonded silica and a phosphate buffer/acetonitrile mobile phase with detection at 195 nm. A standard operating procedure (SOP) for the method was written and another college received the method transfer with the associated glucosamine tablets and performed their own validation following the transferred SOP on a similar instrument. We will describe the method development and validation as well as the SOP that was transferred to the other school.

Development and inter-lab transfer of a dissolution testing and HPLC analysis method for glucosamine tablets

248th National Meeting (2014)

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