Analysis method of Halobetasol Propionate Cream
1.1 To lay down a procedure for analysis of Halobetasole Propionate Cream.
2.1 This procedure is applicable to the analysis of Halobetasole Propionate Cream. in quality control laboratory
3.1 Q.C- Chemist
4.1 Manager-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.
Halobetasol Propionate USP 0.05%w/w
Estimation of Halobetasol Propionate:
Method of Halobetasol Propionate:
Buffer: 3.895 gm. Disodium hydrogen phosphate. and 3.4023 gm of potassium dihydrogen phosphate 1000ml distilled water.
Mobile phase: Buffer : Methanol
45 : 55
Standard preparation: Dissolve and 25 mg Halobetasole propionate. Further dilution 2.0ml to 100.0ml volumetric flask with Mobile phase.
Sample preparation: Weight accurately 1gm.of sample. 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.
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|1.0||STP||Standard Testing Procedure|
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