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Ultra-Violet Assay Method for Erythromycin Tablets

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 established comparative study with microbiological assay of antibiotics.

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4 Comments

  1. From which pharmacopeia has this method referred?

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  2. From which pharmacopeia this method is taken?

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  3. From which pharmacopeia is this method taken?

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    Replies
    1. It's in-house developed method. Analyst have to perform method validation. Also needs to perform comparative study with microbial assay of antibiotics

      Delete

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