Analysis method of Fluconazole Gel
1.1 To lay down a procedure for analysis of Fluconazole Gel.
2.1 This procedure is applicable to the analysis of Fluconazole Gel.in quality control laboratories
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.
Fluconazole IP 0.5%
Estimation of Fluconazole:
Method of Fluconazole:
Buffer: dissolving 1.36 g of potassium dihydrogen orthophosphate in 1000 ml of water. adjusted to pH 3.6 with orthophoshoric acid,
Mobile phase: Buffer : Methanol
60 : 40
Standard preparation: Dissolve 50mg of Fluconazole in 100ml volumetric flask with mobile phase Further dilution 5.0ml to 50.0ml volumetric flask with mobile phase.
Sample preparation: Weight accurately equivalent to 5 mg. sample of Fluconazole, shake with 50 ml of mobile phase and dissolve. dilute the volume 100 ml volumetric flask with mobile phase.
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|