Analysis method of alobetasol Propionate with Fusidic Acid Cream
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Halobetasole Propionate with Fusidic Acidcream.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Halobetasole Propionate with Fusidic Acid cream. In quality control laboratory
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE:
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 Identification:
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.
5.4 Assay:
Composition:
Halobetasol Propionate USP 0.05% w/w
Fusidic Acid IP 2.0% w/w
Estimation of Halobetasol Propionate & Fusidic Acid:
Method of Halobetasol Propionate
By HPLC
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 25 mg Halobetasole propionate diluted to 100 ml volumetric flask. 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.
Chromatographic condition:
Wavelength -263nm
Flow rate – 1ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Calculation:
Method of Fusidic Acid:
Buffer: 1.0% Solution of orthophoshoric acid.
Mobile phase: A mixture of 50 volumes Acetonitrile,20 volumes of water,20 volumes of 1.0% solution of orthophoshoric acid and 10 volume of Methanol.
Standard preparation: Dissolve 50 mg Fusidic acid diluted to 100 ml volumetric flask. Further dilution 10.0ml to 50.0ml volumetric flask with Mobile phase.
Sample preparation: Weight accurately 500mg.of sample wt. heat until the cream has melted and shake for 15 minute. Cool the mixture below 100 diluted
to 100 ml volumetric flask with Mobile phase.
Chromatographic condition:
Wavelength -235nm
Flow rate – 2ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
6.0 ABBREVIATION
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | NM | Nano Meter |
7.0 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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