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Amoxycillin and Clavulanic Acid Tablets USP

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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Dear Members,
Does anyone have experience to perform USP determination method for Amoxycillin and Clavulanic Acid Tablets? We found trouble when trying to prepare sample solution:

Dissolve not fewer than 10 Tablets, accurately counted, in water with the aid of mechanical stirring, transfer to a suitable volumetric flask, dilute with water to volume, and mix. Filter a portion of this solution, discarding the first 10 mL of the filtrate. Dilute an accurately measured volume of the filtrate quantitatively and stepwise with water to obtain a solution containing about 0.5 mg of amoxicillin per mL. Use this Assay preparation within 1 hour.

Amoxycillin is slightly soluble in water and in methanol. Clavulanate Potassium is moisture-sensitive, freely soluble in water, but stability in aqueous solution is not good, optimum stability at a pH of 6.0 to 6.3; soluble in methanol, with decomposition. So, we could not add any organic solvent to increase amoxycillin solubility.

Should we use higher capacity of volumetric flask (2 - 5 L) to follow the procedure?

How many replication should be perform? Within 1 hour we only got 2 run of analysis.

Regards,
Siswanto

Yes. Since the "suitable volumetric flask" is not specified, you get to determine what that is.
Mark Tracy
Senior Chemist
Dionex Corp.
2 posts Page 1 of 1

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