Analysis method of Luliconazole Cream
1.1 To lay down a procedure for analysis of Luliconazole Cream.
2.1 This procedure is applicable to the analysis of Luliconazole 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.
Luliconazole IP 1.0%
Estimation of Luliconazole:
Method of Luliconazole:
Buffer: dissolving 1.0 ml orthophoshoric acid in 1000 ml of water.
Mobile phase: Buffer : Acetonitrile
15 : 85
Solvent Mixture: Methanol.
Standard preparation: Dissolve 50mg of Luliconazole in 100ml volumetric flask with Solvent mixture. Further dilution 5.0ml to 50.0ml volumetric flask with Solvent mixture.
Sample preparation: Weight accurately equivalent to 5 mg. sample of Luliconazole. Shake with 50 ml of Methanol and dissolve. dilute the volume 100 ml volumetric flask with Solvent mixture.
Flow rate – 1ml/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|