Sertaconazole Nitrate Cream

Sertaconazole Nitrate contains Sertaconazole Nitrate in a suitable base.

Sertaconazole Nitrate Cream contains not less than 90.0 per cent and not more than 110.0 per cent of the stated amount of sertaconazole nitrate, C20H15Cl3 N2OS in a suitable cream base.

Usual strength. 2 per cent w/w.

Identification

In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the principal peak in the chromatogram obtained with the reference solution.

Tests

pH (2.4.24). 3.0 to 4.5

Other tests. Comply with the tests stated under Creams.

Assay. Determine by liquid chromatography (2.4.14).

Test solution. Disperse a quantity of the cream containing about 20 mg of Sertaconazole Nitrate in 70 ml of the methanol and sonicate for 15 minutes with intermittent shaking. Cool to room temperature and dilute to 100.0 ml with methanol and filter. Further dilute 5.0 ml of this solution to 25.0 ml with methanol.

Reference solution. A 0.004 per cent w/v solution of sertaconazole nitrate RS in methanol.

Chromatographic system

     –   a stainless steel column 15 cm x 4.6 mm, packed with nitrile groups chemically-bonded to porous silica particles (5 µm), (Such as Zorbax SB CN),

     –   column temperature: 40º,

     –   mobile phase: a mixture of 40 volumes of a buffer solution prepared by dissolving 1.5 g of sodium dihydrogen phosphate monohydrate in 1000 ml of water and 60 volumes of methanol,

     –   flow rate: 1 ml per minute,

     –   spectrophotometer set at 220 nm,

     –   injection volume: 10 µl.

Inject the reference solution. The test is not valid unless the column efficiency is not less than 2000 theoretical plates, the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent.

Inject the reference solution and the test solution.

Calculate the content of C20H15Cl3 N2OS in the creams.

Storage. Store at a temperature not exceeding 25º. Do not freeze.