May 1, 1988

Stability of amoxicillin trihydrate-potassium clavulanate in original containers and unit dose oral syringes

American Journal of Hospital Pharmacy
Y H TuR B Greenwood


The stability of reconstituted amoxicillin trihydrate-potassium clavulanate oral suspension both in original containers and pre-packaged in commercially available oral syringes stored at various temperatures was determined. Amoxicillin trihydrate 125 mg/5 mL-potassium clavulanate 31.25 mg/5 mL and amoxicillin trihydrate 250 mg/5 mL-potassium clavulanate 62.5 mg/5 mL were reconstituted according to the manufacturer's instructions. The reconstituted suspensions in the original containers and in five brands of oral syringes were stored at 5 degrees C and 25 degrees C and -10 degrees C, 5 degrees C, and 25 degrees C, respectively, for 0, 2, 4, 7, and 14 days. The concentrations of amoxicillin trihydrate and potassium clavulanate remaining after storage were assayed in triplicate by reverse-phase high-performance liquid chromatography, using a stability-indicating method. An F statistic was calculated to determine whether different syringe brands had significantly different effects on drug stability. Amoxicillin trihydrate was stable for at least 10 days in the original containers and all types of oral syringes at 5 degrees C. However, potassium clavulanate was stable for 11.1 days in original containers and less than 5 days in all ...Continue Reading

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Mentioned in this Paper

Amoxicillin Trihydrate
Clavulanate potassium
Clavulanic Acids
High Pressure Liquid Chromatography Procedure
Hypodermic Syringes
Drug Storage
Syrinx Formation
Drug Stability
Drug Packaging

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