Amoxycillin and Clavulanic Acid Tablets USP
Posted: Mon Nov 13, 2006 8:17 am
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
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