Analysis method of Sertaconazole Nitrate Cream
1.1 To lay down a procedure for analysis of Sertaconazole Nitrate Cream.
2.1 This procedure is applicable to the analysis of Sertaconazole Cream.in quality control laboratory
3.1 Q.C- Chemist
4.1 Head-Quality Assurance
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution.
5.3 Average fill weight: Weigh accurately bulk of 20 tube and calculate the average fill weight.
Average fill Weight = fill weight of 20 tube/20.
Sertaconazole Nitrate B.P 2% w/w
Estimation of Sertaconazole Nitrate:
Method of Sertaconazole Nitrate:
Buffer: 1.38 gm. Of Monobasic sodium phosphate sufficient water to produced 1000 ml.
Mobile phase: Buffer : Acetonitrile
20 : 80
Standard preparation: Dissolve 100mg of Sertaconazole Nitrate in 100ml volumetric flask with Acetonitrile.
Further dilution 5.0ml to 50.0ml volumetric flask with Acetonitrile.
Sample preparation: Weight accurately equivalent to 10 mg. sample of Sertaconazole Nitrate and
Dissolve. dilute the volume 100 ml volumetric flask with Acetonitrile.
Flow rate – 1.2 ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Temperature – Ambient.
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.0||STP||Standard Testing Procedure|
|Sr. No.||Reference Title|