Each Film Coated Tablet Contains:
Erythromycin Stearate equivalent to Erythromycin 250mg
Preparation of 0.2 M KH2PO4:
Dissolve 13.61g of potassium dihydrogen orthophosphate in 500ml of distilled water.
Preparation of 0.2 M NaOH:
Dissolve 4g of NaOH in 500ml of distilled water.
Preparation of buffer solution:
Mix uniformly 250ml of 0.2M potassium dihydrogen orthophosphate and 250ml of 0.2M NaOH and adjust the pH 8 with sodium hydroxide or potassium dihydrogen orthophosphate.
Preparation of Diluent:
Buffer Solution pH 8 : Methanol (25:25, v/v)
Preparation of Standard Solution:
Weigh & transfer 138.8mg of Erythromycin Stearate SRS in 50mL volumetric flasks, add 10mL of diluent to dissolve & dilute with buffer solution to volume. Dilute 1mL of this solution to 25mL with buffer solution.
Preparation of Sample Solution:
Weigh & powder 20 tablets. Transfer accurately weigh tablet powder equivalent to 138.8mg of Erythromycin Stearate in 50mL volumetric flasks, add 10mL of diluent to dissolve & dilute with buffer solution to volume. Dilute 1mL of this solution to 25mL with buffer solution.
Filter the standard and sample solution and measure the absorbance at 280 nm.
Calculation:
Calculate the % Assay of Erythromycin by using the following formula:
Where,
At = Average Absorbance of Sample
As = Average Absorbance of Standard
Ws = Weight standard
Wt = Weight of Sample
L = Label claim
P = Potency of standard
NOTE: Analyst have to perform Method Validation as per Regulatory Guidelines. Also needs to establish comparative study with the microbiological assay of antibiotics.
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