Amoxicillin Trihydrate Lab Report

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Twenty tablets were weighed accurately and powdered. An amount of the powder equivalent to 5 mg of amoxicillin trihydrate (content of one tablet) was dissolved in 60 ml of diluent. The solution was stirred for 10 min using a magnetic stirrer and filtered into a 100 ml volumetric flask through 0.45µ nylon membrane filter. The residue was washed 3 times with 10 ml of diluent and then the volume was completed to 100 ml with the same solvent. This solution was diluted with diluents to gae a concentration of 0.1 mg/ml solution each of Amoxicillin trihydrate. The HPLC method was applied to the solutions and the results obtained were shown in table 4.6.11.
System suitability solution: 25.0 µg/mL each of of USP Amoxicillin RS in Diluent.
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Acceptable criteria: % Assay should not vary by ±1%.
7.4.7. Specificity
A solution of mixture of Amoxicillin trihydrate and its impurities was prepared by spiking of all three targetted impurities at a level of 0.01%.
Acceptable criteria: Resolution of NLT 1.5 from primary peak

A standard solution of 25 µg mL-1of Amoxicillin trihydrate (in triplicate) was prepared and same was injected, then the system suitability parameters were calculated.
Theoretical plates per meter Theoretical plates per meter were calculated from the data obtained from the peak using the following expression n = (5.54Vr2)/LWh2
Theoretical plates per column Theoretical plates column were calculated from the data obtained from the peak. n = (5.54Vr2)/Wh2
Where, ‘n’ is number of theoretical plates per meter, ‘Vr’ is the distance along the base line between the point of injection and a perpendicular dropped from the maximum of the peak of interest and ‘Wh’ is the width of the peak of interest at half peak
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