Analysis method of Hydroquinone Cream
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Hydroquinone Cream.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Hydroquinone 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:
Hydroquinone USP 2.00% w/w
Estimation of Hydroquinone:
Method of Hydroquinone:
By HPLC
Mobile phase: Acetonitrile: Methanol
90 : 10
Standard preparation: Weight Accurately 40 mg. of Hydroquinone, add 50 ml Acetonitrile solution sonicates 20 minute and dilute 100 ml
volumetric flask. Further dilution Tretinoine 5 ml to 50ml volumetric flask with Acetonitrile.
Sample preparation: Weight accurately about 4 mg of sample wt. Add 50 ml Acetonitrile and sonicate for 20 minute. the volume
was make up 100 ml volumetric flask with Acetonitrile.
Chromatographic condition:
Wavelength -266nm
Flow rate – 0.5ml/mint.
column – C18(250 mm X 4.6) (5μm),
Injection volume – 20 µl.
Column temp. – Ambient.
Record the Chromatogram and measure the peak response of the measure the peaks. Calculate the content of Hydroquinone and Tretinoine Respectively.
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 |
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