Analysis method of Torsemide Injection


Analysis method of Torsemide Injection

1.1 To lay down a procedure for Analysis of Torsemide Injection.

2.1 This procedure is applicable to the Analysis of Torsemide Injection. in Quality control

3.1 Q.C- Chemist


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 10 ml 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 SOP

11.0 Bacterial endotoxins: –
Injection comply with the test of Bacterial endotoxin as per SOP
12.0 Composition: –
Each ml contains:
Torsemide USP 10 mg.

14.0 Assay: – NLT 90.0% and NMT 110.0%
Method of Torsemide: – Determine by liquid chromatography.
Buffer: Dissolve in 0.02 M Phosphate buffer in water adjust to pH 3.5 with Orthophoshoric acid.

Mobile phase: – Methanol: Water
50 : 50

Standard preparation: -Weight accurately about 30 mg working standard of Torsemide add 50 ml methanol mix and sonicate to dissolve.

And diluted to 100 ml of mobile phase phase.

Sample preparation: -Take sample equivalent about 30 mg working standard of Torsemide add 50 ml methanol mix and sonicate to dissolve.

And diuted to 100 ml of mobile phase.

Chromatographic condition: – Wavelength-288 nm
Flow rate 1.5 ml per minute
Injection volume- 20 µl.
Column- C18 15cm x 4.6 mm (5 µm)

Record the Chromatogram and measure the peak response of the measure peaks. Calculate the content of Torsemide Respectively.

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.




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


Sr. No.           Reference Title
01               IHS

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