Analysis of diclofenac gel

1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Diclofenac GEL.

2.0 SCOPE

2.1 This procedure is applicable to the analysis of Diclofenac GEL.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. by chemical method.
5.3 pH: Taken sample 5 gm diluted in 100 ml water.
5.4 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:
Diclofenac Diethylamine 1.16 % w/v

Assay: NLT 90.0% and NMT110.0%

Method of Diclofenac diethylamine: Determine by liquid chromatography.
Buffer: 0.1 percent w/v Orthophoshoric acid and 0.16 percent w/v sodium dihydrogen

orthophosphate diluted Adjust to pH 2.5 Orthophoshoric acid

Mobile phase: Buffer: Methanol
20 : 80

Standard preparation: Weight accurately about 50 mg Working standard of

Diclofenac sodium in 100 ml of mobile phase.

Further dilution 5 ml to 50 ml with mobile phase.

Sample preparation: Take sample equivalent to 50 mg of Diclofenac sodium in 100 ml of mobile phase.

Further dilution 5 ml to 50 ml with mobile phase.
Chromatographic condition: Wavelength-254 nm
Flow rate 1.0 ml /mint.
Injection volume- 20 µl.
Column- C8 250 x 4.6 mm bonded to porous silica 5µm.
Retention time about 14.5 mint.

Record the Chromatogram and measure the peak response of the measure peaks.

Calculate the content of Diclofenac Sodium Respectively. Retention time of the Principal peak is about 15 minute

Calculation:

– Area of spl Wt. of std

………………… X……………………. X 100 X % Potency of Standard

– Area of std Wt. of spl

Procedure: – Inject Blank in single injection, Standard preparation in Replicates of three, test preparation in duplicate injection.

System suitability: – % RSD of three replicate injections should not be more than 2.0.

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