Assay of Cefadroxil by HPLC in tablet dosage form

BACKGROUND

Among first-generation available cephalosporins, Cefadroxil is a broad-spectrum antibiotic acting both on Gram-negative bacterial and Gram-positive infections. Few diseases which are treated using cefadroxil are reproductive tract infection, tonsillitis, urinary tract infection, and skin infections.¹  

The Molar mass of Cefadroxil is 363.389 g/mol and molecular formula is C₁₆H₁₇N₃O₅S. For quantifying the API content in tablet dosage form the following procedure is prescribed by Indian pharmacopoeia.² 

REQUIREMENTS

• Cefadroxil active pharmaceutical ingredient
• Cefadroxil tablets
• Dihydrogen phosphate
• Potassium hydroxide
• Acetonitrile
• Volumetric flask
• Mortar pestle
• Weighing balance
• 0.45 µm filter paper
• Water
• High Performance Liquid Chromatography
• Column [C18 column (25 cm x 4.0 mm, 5 μm)]

PROCEDURE

Buffer solution

Phosphate buffer solution pH 5.0

Dissolve 2.72 g of potassium dihydrogen phosphate in a glass beaker containing about 900 ml of water. Adjust the pH to 5.0 with potassium hydroxide and make up the volume to 1000 ml with water.

Mobile phase

Mix buffer: acetonitrile in the ratio of 96:04

Diluent

Phosphate buffer solution pH 5.0

Standard solution

Weight 30 mg of cefadroxil (API) in 100 ml volumetric flask containing about 50 ml of diluent, mix well and make up the volume up to 100 ml by diluent.

Sample solution

Triturate 20 no of cefadroxil tablets in a mortar pestle. Weight equivalent to 30 mg of powdered sample in a 100 ml volumetric flask containing about 50 ml of diluent, shake vigorously to dissolve complete for about 10 -15 minutes, make up the volume up to 100 ml by diluent. Filter sample solution by 0.45 µm filter paper.

Chromatographic conditions

C18 column (25 cm x 4.0 mm, 5 μm)

Mobile phase flow rate 1.5 ml/min

Detection wavelength 230 nm

Injection volume 20 μl

Run the HPLC only with mobile phase atleast for 10 minutes for conditioning of column.

Now inject standard solution six times by taking solution from volumetric flask each time and record the response/area. Similarly inject filtered sample solution six times by taking solution from volumetric flask each time and record the response/area.

Observation table

Sl. No.	Standard Area	Sample Area
1
2
3
4
5
6
Avg.
% RSD	<2.0	<2.0

Calculation

Ensure that % RSD obtained from six injections should not exceed 2.0

Content of cefadroxil (mg/tab) =

CONCLUSION

The content of cefadroxil (market brand) tablet found to be ____.

REFERENCES

1. Cefadroxil. Available at: https://www.revolvy.com/main/index.php?s=Cefadroxil.
2. Indian Pharmacopoeia.

Also read:

• Assay of Azithromycin by HPLC in tablet dosage form
• Preparation and standardization of sulfuric acid
• Determination of the concentration of potassium ion using Flame Photometry
• Preparation and standardization of ceric ammonium sulphate
• Acute toxicity testing for topical preparations
• Calculation of Body Surface Area (Using a Nomogram)
• Estimation of white blood cell count (TLC/ Total Leucocyte Count)

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