Analysis method of Sertaconazole Nitrate Cream
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Sertaconazole Nitrate Cream.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Sertaconazole Cream.in quality control laboratory
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Head-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.
6.0 Assay:
Composition:
Sertaconazole Nitrate B.P 2% w/w
Estimation of Sertaconazole Nitrate:
Method of Sertaconazole Nitrate:
By HPLC
Buffer: 1.38 gm. Of Monobasic sodium phosphate sufficient water to produced 1000 ml.
Mobile phase: Buffer : Acetonitrile
20 : 80
Standard preparation: Dissolve 100mg of Sertaconazole Nitrate in 100ml volumetric flask with Acetonitrile.
Further dilution 5.0ml to 50.0ml volumetric flask with Acetonitrile.
Sample preparation: Weight accurately equivalent to 10 mg. sample of Sertaconazole Nitrate and
Dissolve. dilute the volume 100 ml volumetric flask with Acetonitrile.
Chromatographic condition:
Wavelength -260nm
Flow rate – 1.2 ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Temperature – Ambient.
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 | Ml | Milli-liter |
| 4.0 | I.P. | Indian Pharmacopeia |
| 5.0 | NM | Nano Meter |
7.0 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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