Standard Testing Procedure diclofenac sodium injection
1.0 OBJECTIVE
1.1 To lay down a procedure for Analysis of Diclofenac sodium injection
2.0 SCOPE
2.1 This procedure is applicable to the Analysis of Diclofenac sodium injection
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance
5.0 Identification: In the assay the principal peak in the chromatogram obtained with the test solution corresponds to the peak in
the chromatogram obtained with the reference solution.
6.0 Description: Pour 10ml finish sample in Beaker and observed Visually.
7.0 pH: Taken 40ml sample in beaker the pH. electrode first with purified water followed by sample dip the electrode in sample and observe the pH.
8.0 Extractable volume: Measured the volume by Measuring cylinder and determine the volume.
9.0 Particulate matter: Injections that are solutions, when examine under suitable conditions of visibility are clear and practically free
from particles that can be observed on visual inspection by the unaided eye.
10.0Sterility: Injection comply with the test for sterility as per STP
11.0 Bacterial endotoxins: –
NMT 4.67 Endotoxins unit/mg of Diclofenac sodium as per STP
12.0 Composition: –
Each ml contains:
Diclofenac sodium I.P. 75mg.
13.0 Assay: NLT 95.0% and NMT105.0%
Method of Diclofenac sodium: Determine by liquid chromatography.
Buffer: 1.6 gm Sodium Dihydrogen Orthophosphate anhydrous diluted to 1000 ml water. Add 1 ml Orthophoshoric acid. Adjust to pH 2.5 with sodium hydroxide.
Mobile phase: Buffer: Methanol
34 : 66
Standard preparation: Weight accurately about 75 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 75 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- 10 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 minutes.
Calculation:
Area of spl Wt. of std
………………… X……………………. X 100 X % Potency of Standard X 1
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.
14.0 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 |
15.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | I.P. |
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