Analysis method of Clobetasol Propionate and Salicylic Acid Ointment
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Clobetasol Propionate and Salicylic Acid Ointment.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Clobetasol Propionate and Salicylic Acid Ointment. 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:
Clobetasol Propionate IP 0.05% w/w
Salicylic Acid IP 6.0% w/w
Estimation of Clobetasol Propionate & Salicylic Acid:
Method of Clobetasol Propionate& Salicylic Acid:
By HPLC
Buffer: 6.8 gm of potassium dihydrogen phosphate 1000ml distilled water.
Mobile phase: Buffer: Methanol: Acetonitrile
50 : 25 : 25
Diluent: Buffer: Methanol
46 : 54
Standard preparation: Dissolve 60mg of Salicylic Acid in 100ml Volumetric flask add 20ml with methanol (solution A). and 25 mg.
Clobetasol propionate diluted to 100 ml volumetric flask with methanol. Further dilution 2.0ml to 100.0ml volumetric flask with diluent (Solution A).
Sample preparation: Weight accurately 1gm.of sample wt. Add 20ml Methanol content was heated in a water bath at about 650 for 15 minute and cool at room temp.
the volume makes up 100 ml volumetric flask with diluent.
Chromatographic condition:
Wavelength -240nm
Flow rate – 1ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Calculation:
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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