Site icon Pharma Dekho

Standard Testing Procedure diclofenac sodium injection

 

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.

Analysis of vitamin B1 B6 B2 Nicotinamide and sodium pentothenate Injection

Analysis for Nandrolone Decanoate injection

Analysis of Dicyclomine and Diclofenac sodium Injection

standard testing procedure of Fexofenadine and Phenylephrine suspension

standard testing procedure of Piroxicam Injection

STP of Fungal Diastase and Papain capsules

standard testing procedure PVC

standard testing procedure glass ampoule

Standard testing procedure of Iron Sucrose Injection

Standard testing procedure lactose

Standard testing procedure mefenamic acid

standard testing procedure domperidone

standard testing procedure flavour mixed fruit

standard testing procedure dicyclomine hydrochloride

Standard testing procedure honey pure

standard testing procedure dextromethorphan hydrobromide

standard procedure of levocarnitine injection

Analysis of Ivermectin Suspension

standard testing procedure artemether injection

standard testing procedure artemether injection

standard testing procedure Carbocisteine syrup

standard testing procedure Phytomenadione injection

standard testing procedure serratiopeptidase

standard testing procedure starch IP

standard testing procedure sucrose refined sugar

standard testing procedure titanium dioxide

standard testing procedure tramadol hydrochloride

standard testing procedure zinc sulphate

standard testing procedure croscarmellose sodium

standard testing procedure colour erythrosine supra

standard testing procedure magnesium hydroxide

standard testing procedure diclofenac sodium

standard testing procedure dibasic calcium phosphate

standard testing procedure cyanocobalamin

standard testing procedure cholecalciferol

standard testing procedure Calcium carbonate oyster shell powder

standard test procedure Calcium Citrate

standard testing procedure Bronopol

standard testing procedure Bromhexine Hydrochloride

Standard Testing Procedure diclofenac sodium injection

Standard Testing Procedure Drotaverine Hydrochloride injection

Standard Testing Procedure Tranexamic acid injection

standard test procedure paracetamol infusion

standard test procedure ofloxacin and ornidazole infusion

standard test procedure ornidazole injection

standard test procedure Ondansetron injection

standard test procedure dextrose injection

standard test procedure ciprofloxacin injection

STP and analysis method of Ammonium Chloride

Analysis method of aceclofenac

Sop for Analysis of cartons

analysis method of Losartan Potassium and Hydrochlorothiazide

analysis method of Linezolid Dry Syrup

analysis method of Drotaverine Hydrochloride and Mefenamic acid

Analysis method of Ceftriaxone Sodium and Sulbactam sodium Injection

analysis method of Cefepime and Tazobactam Injection

 Analysis method of Hydroquinone Cream

 Analysis method of Tacrolimus Ointment

 Analysis method of Terbinafine HCL Cream

 Analysis method of Mometasone Furoate and Fusidic Acid Cream

 Analysis method of Disodium Hydrogen Citrate Syrup

Analysis method of Hydroquinone with Tretinoin Cream

 Analysis method of Hydroquinone Tretinoin and Mometasone Furoate Cream

 Analysis method of Sertaconazole Nitrate Cream

 Analysis method of Halobetasol Propionate Cream

 Analysis method of Povidone Iodine with Ornidazole Ointment

Analysis method of Eberconazole Cream

 Analysis method of Luliconazole Cream

 Analysis method of Fluconazole Gel

Analysis method of Ketoconazole Cream

Analysis method of Salbutamol and Choline theophyllinate Syrup

Analysis method of Methylcobalamin Injection

Analysis method of Piroxicam and paracetamol Injection

Analysis method of Alpha Beta Arteether Injection

Analysis method of Enrofloxacin Suspension

Analysis method of Levetiracetam Syrup

Analysis method of Sucralfate suspension

Analysis method of Sucralfate and Oxetacaine Suspension

Analysis method of Quinine Sulphate Suspension

Analysis method of Calcium Carbonate vitamin D3 Zinc Gluconate and Magnesium hydroxide suspension

Analysis method of Suspension of Tribasic Calcium phosphate with vitamin D3 and Vitamin B12

Analysis method of Calcitriol with calcium citrate Suspension

Analysis method of Oxyclozanide and Fenbendazole Suspension

Analysis method of Oxyclozanide and Levamisole Suspension

Analysis method of Triclabendazole and Ivermectin Suspension

Analysis method of Itraconazole Solution

Analysis method of Levocetirizine Dihydrochloride syrup

Analysis method of Iron Calcium Vitamin D3 Folic Acid Vitamin B12 Suspension

Analysis method of Ferrous Ascorbate Cyanocobalamin and Folic Acid Suspension

Analysis method of Ambroxol Hydrochloride Drops 

Analysis method of Dried Aluminium Hydroxide Magnesium Hydroxide Oxetacaine and Simethicone suspension

Analysis method of Ferrous Ascorbate with Folic Acid suspension

Analysis method of Piracetam Syrup

Analysis method of Rafoxanide and Levamisole suspension

Analysis method of Zinc gluconate Syrup

Analysis method of Magaldrate Simethicone and Oxetacaine suspension

Analysis method of mefenamic acid and paracetamol suspension

Analysis method of Cholecalciferol Drops

Analysis method of Racecadotril suspension

Analysis method of Deflazacort Suspension

Analysis method of Montelukast sodium and levocetirizine Dihydrochloride Syrup

Analysis method of Iron and Folic Acid Syrup

Analysis method of Cyproheptadine Hydrochloride and Tricholine Citrate Syrup

Analysis method of Paracetamol Phenylephrine hydrochloride and Chlorpheniramine Maleate in oral liquid

Analysis method of Levofloxacin Hemihydrate Ornidazole and Vitamin E Solution

Analysis method of Albendazole and ivermectin in oral liquid

Exit mobile version