Analysis method of Ketoconazole Cream
1.1 To lay down a procedure for analysis of Ketoconazole Cream.
2.1 This procedure is applicable to the analysis of Ketoconazole Cream.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.
Ketoconazole IP 2%
Estimation of Ketoconazole:
Method of Ketoconazole:
Solvent mixture. Equal volumes of methanol and dichloromethane.
Mobile phase: A mixture of 7 volumes of 0.2 per cent w/v solution of di-isopropyl -amine in methanol, and 3 volumes of a 0.5 per cent w/v solution of ammonium acetate,
Standard preparation: Dissolve 20mg of ketoconazole 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 2 mg. sample of ketoconazole, shake with 50 ml of solvent mixture sonicate and dissolve dilute the volume 100 ml volumetric flask with solvent mixture.
Flow rate – 2 ml/mint.
column – C18(300 mm X 3.9) (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|